Atropine therapy versus no atropine therapy for the prevention of adverse events in paediatric patients undergoing intubation

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

The objective of this review is to identify and evaluate all RCTs comparing premedication for paediatric endotracheal intubation with the use of atropine to paediatric endotracheal intubation without the use of atropine, and to quantify the effect of using atropine as a premedication in paediatric endotracheal intubation on adverse clinical outcomes.

Background

Description of the condition

Endotracheal intubation in paediatric patients is a fundamental skill required for the practice of medicine in a multitude of settings, from the emergency department (ED) to the operating room. The goal of endotracheal intubation is to place a temporary but secure airway within the trachea, thus allowing for establishment or protection of the airway and to provide manual or mechanically assisted ventilation. In paediatric patients, intubation may be considered for any number of reasons that include elective or emergency surgical procedures, medical management of respiratory illness, altered level of consciousness, or to simply decrease metabolic demand. Regardless of the indication, endotracheal intubation is a high-risk procedure requiring that the physician assume control of the respiratory system by attempting visualization of the glottis and successfully passing a tube into the trachea via the mouth or nose.

Assuming control of a patient's airway can result in undesirable physiologic responses in the patient. Hypoxaemia, bradycardia, and hypotension are potential physiologic responses to intubation that have been reported in paediatric studies (Fastle 2004; McAllister 1999; Nishisaki 2013). In one study of paediatric intubations in an intensive care unit setting, in nearly 2000 intubation events, the rate of hypotension requiring intervention was as high as 3.4% (Nishisaki 2013). In addition, more than one intubation attempt in a single encounter has been associated with higher rates of undesirable physiologic responses (Nishisaki 2013).

The reported incidence of bradycardia in paediatric intubation varies. In a commonly referenced retrospective cohort study of all paediatric intubations in an urban children’s hospital over the course of four years, there were only six instances (4%) of bradycardia out of a total of 143 intubations (Fastle 2004). In a randomized controlled trial (RCT) examining paediatric intubation facilitated by sevoflurane versus no medication, the incidence of bradycardia in the awake group was as high as 44.4% (Hassid 2007). Bradycardia is thought to occur for several reasons, secondary to vagal stimulation from the intubation equipment, laryngoscopy blade, or endotracheal tube; secondary to hypoxia resulting from the removal of the patient’s drive to breathe with sedative agents; or as a result of adverse effects from other commonly used premedication agents (mainly succinylcholine).

In a study of preterm infants, Marshall (Marshall 1984) proposed that the bradycardia observed during endotracheal intubation was the result of parasympathetic stimulation involving the vagal nerve. Basic physiology supports this theory as the vagus nerve plays a role in lowering the intrinsic heart rate in normal individuals. The pharynx, oesophagus, and respiratory tract contain afferent vagal fibres that may come in contact with the laryngoscope blade or endotracheal tube resulting in an increased parasympathetic tone. To compound this effect, infants and children may have a more sensitive or pronounced vagal response to intubation than adults (Fastle 2004).   

Sedative agents used in premedication often completely remove the patient’s ability to drive respiration. Oxygen is required for normal neuronal and electrical conduction through the cardiac conduction system (Guyton 2006). Apnoeic conditions that cause hypoxia result in stimulation of peripheral chemoreceptors and subsequent bradycardia (Alboni 2011). As a study by Wennergren suggests, bradycardia induced by the aforementioned vagal reflex may be more pronounced in the presence of underlying hypoxia (Wennergren 1989). In this way, the bradycardic response to physical instrumentation of the airway may be compounded if the patient becomes hypoxic during the intubation sequence.

The use of paralytic agents is a fundamental aspect of premedication. A popular agent for this purpose is succinylcholine. Succinylcholine is a depolarising paralytic agent, formed from two molecules of acetylcholine linked together. In addition to direct stimulation of cholinergic receptors at the neuromuscular junction, it also stimulates muscarinic and nicotinic receptors in the autonomic nervous system thus enhancing the parasympathetic drive. It is through the latter mechanism that succinylcholine is thought to precipitate sinus bradycardia and other bradycardic cardiac rhythms (Miller 2010).

Description of the intervention

The pre-emptive administration of atropine is commonly employed in order to avoid bradycardia associated with intubation. Atropine sulfate, given for the indication of premedication for intubation, is typically given intravenously in a dose of 0.02 mg/kg per dose to a maximum of 0.5 mg/dose (American Heart Association 2011). Atropine may also be administered to reduce airway secretions.

A standard intubation procedure consists of pre-oxygenation and preparation of the patient, administration of anaesthesia, administration of neuromuscular blockade, direct laryngoscopy, and passage of an endotracheal or nasotracheal tube (hereafter named 'intubation sequence'). Other scenarios require alternate approaches to intubation; in cardiac arrest anaesthesia is often omitted. In rapid sequence induction, the patient is believed to be at higher risk for aspiration of gastric contents, and the patient is therefore administered neuromuscular blockade at the time of induction of anaesthesia. Finally, patients may be intubated in an awake fashion with subdissociative doses of anaesthetic agents or topical anaesthesia. When atropine is administered in any intubation it is typically given prior to neuromuscular blockade and prior to direct laryngoscopy (that is prior to anticipated bradycardia from the mechanisms mentioned above, and prior to direct laryngoscopy that could be obscured by airway secretions).

How the intervention might work

Atropine sulfate, a competitive antagonist of muscarinic acetylcholine receptors, is classified as an anticholinergic agent (Lucking 2012). Anticholinergic agents, by definition, reduce the effect of the parasympathetic nervous system and, in doing so, block the effects of the vagus nerve. By blocking vagal activity, atropine allows for increased stimulation of the sinoatrial node and conduction through the cardiac electrical system resulting in contraction of the cardiac muscle. Because bradycardia is associated with anaesthesia, paralysis and direct laryngoscopy is thought to be predominantly vagally mediated, atropine is a natural choice for counteracting these effects. In addition to increasing heart rate, atropine also plays a role in reducing respiratory secretions, effectively 'drying out' the airway and facilitating visualization of the glottis.

Why it is important to do this review

Evidence of bradycardia during paediatric intubation dates back to the 1950s (Leigh 1957). While these studies raised the initial question of bradycardia during the intubation procedure, most are small, non-randomized, and often report atypical conditions; such as multiple doses of succinylcholine (Lupprian 1960). As recent as this year, the routine use of atropine has been supported in published literature (Jones 2013), "atropine reduces the prevalence of arrhythmias and conduction disturbances during intubations, which may contribute to the safety of the procedure...". Accordingly, current guidelines recommend that all children under one year of age, any child aged one to five years who will also receive the paralytic succinylcholine, and any child over the age of five years who receives a second dose of succinylcholine should also receive a dose of intravenous atropine sulfate (American Heart Association 2011). This recommendation is pervasive in the paediatric literature (American Heart Association 2011Fleisher 2010Gerardi 1996) and is the standard practice amongst physicians intubating children and infants.

Despite this climate, the practice has several times been called into question (McAuliffe 1995; Mirakhur 1978). These early studies are small and predominantly anaesthesia based, but in some countries surveys from the 1990s suggested that the pendulum was swinging and routine use of atropine was not common practice (Parnis 1994; Warde 1995). Despite this, national guidelines recommended the routine use of atropine in specific paediatric populations. Prompted by this resistance to change, a narrative review was completed by Fleming. The review examined the previous literature and proposed that: “atropine premedication for emergency department rapid sequence intubation is unnecessary and should not be viewed as ‘standard of care’” (Fleming 2005). A retrospective cohort study, published in 2004, also concluded that pretreatment with atropine did not always prevent bradycardia (Fastle 2004). This study was included in a “BestBET” on the topic and published in 2007 examining the effectiveness of atropine to reduce reflex bradycardia during rapid sequence induction. The authors went on to conclude that the incidence of bradycardia was less frequent than previously reported, that hypoxia was likely to be the main contributing factor to bradycardia, and that there was evidence suggesting the use of atropine was unnecessary (Bean 2007).

Reflective of the contradictory climate, some paediatric texts acknowledge the lack of evidence surrounding the issue but maintain the recommendation (Fleisher 2010), while others no longer recommend routine use of atropine in the paediatric intubation sequence (Walls 2008). While recent publications raise the issue, the authors of this paper believe that a more rigorous look at the literature is warranted. Therefore, the current contradictory recommendation regarding the role of atropine in endotracheal intubation of children demands a formalized systematic review to synthesize the existing evidence.

Objectives

The objective of this review is to identify and evaluate all RCTs comparing premedication for paediatric endotracheal intubation with the use of atropine to paediatric endotracheal intubation without the use of atropine, and to quantify the effect of using atropine as a premedication in paediatric endotracheal intubation on adverse clinical outcomes.

Methods

Criteria for considering studies for this review

Types of studies

We will include all RCTs comparing atropine administration to no atropine administration in the premedication sequence of the intubation procedure. We will include studies of blinded and unblinded patients.

We will not limit studies based on language of publication or publication status.

Types of participants

We will include studies of patients (male or female) aged between 28 days and 18 years who are undergoing tracheal intubation, by either the nasopharyngeal or oropharyngeal route, for any purpose in any clinical setting. We will exclude studies of premature and term neonates.

Types of interventions

We will include studies that used single or multiple dose regimens of atropine, in any dose and by any route of administration, given that the atropine was provided as part of the intubation sequence.

Types of outcome measures

Primary outcomes

Each outcome will be considered from the period of premedication for the preparatory phase of intubation until successful placement of the nasotracheal or orotracheal intubation tube.

1. Bradycardia (rate definition will vary with age) (Table 1):

Table 1. Bradycardia by age (American Heart Association 2011)
One month to three months< 85 beats per minute (BPM)
Three months to two years< 100 BPM
Two years to 10 years< 60 BPM
> 10 years< 60 BPM
  • requiring therapeutic intervention;

  • not requiring therapeutic intervention.

Secondary outcomes

Each outcome will be considered from the period of premedication for the preparatory phase of intubation until successful placement of the nasotracheal or orotracheal intubation tube.

2. Tachycardia (rate definition will vary with age) (Table 2):

Table 2. Tachycardia by age (American Heart Association 2011)
One month to three months> 205 beats per minute (BPM)
Three months to two years> 190 BPM
Two years to 10 years> 140 BPM
> 10 years> 100 BPM
  • requiring therapeutic intervention;

  • not requiring therapeutic intervention.

3. Hypotension requiring therapeutic intervention (pressure definition varies with age) (Table 3).

Table 3. Hypotension by age (American Heart Association 2011)
One month to 12 months< 70 mm Hg
One year to 10 years< 70 + (2 X age in years)
< 90Children 10 years and older

4. Dysrhythmia.

We will define 'dysrhythmia' as any change in electrophysiological heart rhythm that is deemed to originate outside of the sinus node (that is not deemed to be sinus tachycardia or sinus bradycardia):

  • requiring therapeutic intervention;

  • not requiring therapeutic intervention.

5. Hypoxia.

We will define 'hypoxia' as any documented oxygen saturation < 95%.

6. Emesis event.

We will define emesis as any regurgitation of gastric contents.

7. Number of intubation attempts.

Search methods for identification of studies

Electronic searches

We will search the Cochrane Central Register of Controlled Trials (CENTRAL) (OvidSP, most recent issue); MEDLINE (OvidSP) (1946 to date); EMBASE (OvidSP) (1980 to date). We will limit the searches to children aged from one month to 18 years, which excludes neonates. We will not use any language limits. We will use the Cochrane highly sensitive search strategy for identifying RCTs in Ovid MEDLINE and Ovid EMBASE (Higgins 2011). 

Our Ovid MEDLINE search strategy is outlined in Appendix 1 and it will be adapted for searching in other databases. The final MEDLINE search strategy as well as the EMBASE and CENTRAL strategies will be reported in full in the final review.

Searching other resources

We will search the World Health Organization (WHO) International Clinical Trials Registry Platform, which includes clinicaltrials.gov, for ongoing trials. We will handsearch the abstracts from major international conferences over the past two years, including the Canadian Anesthesiologists Society, the American Society of Anesthesiologists, the Society of Critical Care Medicine, the American College of Emergency Physicians, the International Pediatric Association Congress of Pediatrics, and the Annual Paediatric Intensive Care Society Conference.

Data collection and analysis

Selection of studies

A primary screening will be completed in which the title and abstract will be read and the study included if it might satisfy the predetermined inclusion and exclusion criteria. Manuscripts deemed eligible for inclusion will be read in their entirety and, again, accepted for inclusion if they meet the predetermined inclusion criteria. Two authors (AW and GT) will complete both screenings. A third author (EL) will settle any disagreements.

Data extraction and management

We will extract the data and both the primary and secondary reviewers (AW and GT) will create separate data tables in Review Manager 5 (Appendix 2). In the event that there are discrepant findings in the data from the extraction process, the third author (EL) will provide clarification. If necessary, we will contact the study author(s) to provide the details on any information missing from the trial.

Broadly, we will collect the information regarding each study’s population, intervention, methods, and outcomes. Each study participant's data will be extracted on an individual basis, if possible. Outcomes of interest include adverse events related to the intubation procedure and adverse and protective effects related to the administration of atropine: tachycardia, bradycardia, hypotension, hypoxia, emesis, and number of intubation attempts.

Assessment of risk of bias in included studies

Each of the two reviewing authors (AW and GT) will independently complete risk of bias tables for each trial included in the review. The risk of bias table will be formatted in keeping with the guidance outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The risk of bias for each trial will be deemed 'high risk', 'low risk', or 'unclear risk' in the following domains.

  1. Random sequence generation.

  2. Allocation concealment.

  3. Blinding of participants and personnel.

  4. Blinding of outcome assessment.

  5. Incomplete outcome data.

  6. Selective reporting.

In addition, we will note in the table any other potential sources of bias and judge each source to be 'high risk', 'low risk', or 'unclear risk'. Each of these statements has specific criteria that are outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). In the event that the two authors (AW and GT) recommend a different assessment of bias for a specific trial, a third author (EL), blinded to the results of the previous assessments, will also complete a risk of bias table.

Each assessment will be supported by a clear justification from each author and, where possible, will include a direct quotation from the trial itself to demonstrate a transparent assessment.

Measures of treatment effect

We will describe dichotomous outcomes (for example emesis: yes versus no) using risk ratios with their associated 95% confidence intervals (CIs). We will describe continuous outcomes (for example blood pressure) using mean differences or standardized means with their associated 95% CIs.

Unit of analysis issues

We will include multiple treatment groups. If studies contain multiple atropine arms (for example different doses) these will be combined (that is treated as one group) in our meta-analysis and compared to the single control group. We will include cluster and cross-over randomized trials (if any) in the meta-analysis. Variances from these studies will be adjusted accordingly due to correlation issues as outlined in the Cochrane Handbook for Systematic Reviews of Interventions, sections 16.3.4 and 16.4.6.1 respectively (Higgins 2011).

Dealing with missing data

We will request any missing data from the authors. If this approach is unsuccessful, we will impute means with medians (if medians are given); otherwise studies with missing means will not be included. If standard deviations are missing, we will calculate them, where possible, using standard errors, P values, CIs, z-statistics, or t-statistics. Failing this method, we will impute the standard deviations from other similar studies.

Assessment of heterogeneity

We will consider clinical heterogeneity before pooling results and examine statistical heterogeneity before carrying out any meta-analysis. We will use the I2 statistic to estimate the impact of heterogeneity on the potential meta-analysis. I2 values that are greater than 50% will be considered to indicate substantial heterogeneity. We will investigate any significant statistical heterogeneity as outlined below.

Assessment of reporting biases

If we have sufficient studies (that is > 10) we will assess publication and reporting biases both qualitatively using a funnel plot and quantitatively using Egger's regression test (Egger 1997).

Data synthesis

When studies are clinically homogenous we will perform a meta-analysis of the data. We will employ the DerSimonian Laird random-effects model in our primary analysis. We will combine dichotomous outcomes using risk ratios, while we will combine continuous outcomes using mean differences or standardized mean differences depending upon the units of analysis of the outcomes. We will analyse statistical heterogeneity using the I2 statistic. We will consider values of greater than 50% as substantial and sources of heterogeneity will be investigated.

Subgroup analysis and investigation of heterogeneity

In the presence of substantial clinical or statistical heterogeneity, we will consider subgroup analyses based on the following characteristics.

  1. Setting of intubation procedure: emergency department versus intensive care unit (ICU) versus other settings.

  2. Technique: Intubation during cardiac arrest versus intubation during rapid sequence induction versus standard intubation versus other (awake, non-paralysed patient).

  3. Medication used: muscle relaxant versus no muscle relaxant.

  4. Age based on the Pediatric Advanced Life Support Guidelines (American Heart Association 2011): a) less than one year; b) greater or equal to one year, while less than five years; c) greater than or equal to five years.

  5. Timing of atropine: in response to bradycardia versus in anticipation of bradycardia.

Sensitivity analysis

We will complete a sensitivity analysis to determine the effect of excluding trials at high risk of bias, as well as any trials where missing data could not be found by the individual study authors. Finally, if a meta-analysis is possible we will examine a fixed-effect model analysis in contrast to our primary random-effects model analysis. If the random-effects and fixed-effect model analyses differ substantially, we must be more cautious of our interpretation of our primary results. We will also perform a sensitivity analysis to determine if the impact of the imputed standard deviations changes the overall outcome of the meta-analysis.

Summary of findings

We will use the principles of the GRADE system (Guyatt 2008) to assess the quality of the body of evidence associated with the specific outcomes bradycardia, tachycardia, hypotension, hypoxia, emesis, and number of intubation attempts in our review and construct a summary of findings (SoF) table using the GRADEPro 3.6 software. The GRADE approach appraises the quality of a body of evidence based on the extent to which one can be confident that an estimate of effect or association reflects the item being assessed. The assessment of the quality of a body of evidence considers the study methodological quality, the directness of the evidence, heterogeneity of the data, precision of the effect estimates, and the risk of publication bias.

Acknowledgements

The primary author would like to acknowledge Dr Izabela Sztukowski for her contributions in developing the concept and ongoing encouragement of this project.

We would like to thank Mike Bennett (content editor), Nathan Pace (Statistical editor), Guillaume Emiraud, Francis Veyckemans, and Ari Joffe (peer reviewers) for their help and editorial advice during the preparation of this protocol for the systematic review.

Appendices

Appendix 1. OvidSP MEDLINE search strategy

1. exp Intubation/ or Intubation, Intratracheal/ or (intubat* or rapid sequence induction).mp.
2. exp Atropine/ or atrop?n*.af.
3. 1 and 2
4. (infant* or preschool* or child* or adolescent*).af.
5. adult*.af.
6. (3 not (5 not (4 and 5))) not neonat*.mp.
7. ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab.) not (animals not (humans and animals)).sh.
8. 6 and 7

Appendix 2. Data Collection Table

 

Review title or ID
     

 

Study ID (e.g. Smith 2001)
     

 

Report IDs of other reports of this study (e.g. duplicate publications, follow-up studies)
     

 

Notes:        

 

 

 

1.    General Information

 

Date form completed      
Reviewer ID number

     

 

Report title  

     

 

Report ID 

     

 

Reference details

     

 

Report author contact details

     

 

Publication type

Full report, abstract, letter, etc.

     

 

Study funding sources

     

 

Possible conflicts of interest for study authors 

     

 

Notes:       

2.    Study Eligibility

 

Study Characteristics

Eligibility Criteria

 

YesNoUnclear

Location in text

(pg & ¶/fig/table)

Types of intervention

Randomized Controlled Trial

 

        
         

Participants

 

>28 days up to and including 18th birthday

 

 

        

Participants

 

Undergoing intubation with placement of endotracheal tube or nasotracheal tube

 

 

        

Types of intervention

 

Recevied atropine (IV, IO or PO) in the pre-medication sequence

 

 

        

Types of intervention

 

Described at least one of the following outcomes:

-        Bradycardia

-        Tachycardia

-        Hypotension

-        Dysrhythmia

-        Hypoxia

-        Emesis

-        >1 intubation attempt

        
INCLUDE  EXCLUDE 
Reason for exclusion      
Notes:         

 

DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW

3.    Population and setting

 

 

Description

Please note any differences between intervention and control groups if available or specified

Location in text

(pg & ¶/fig/table)

Population description           

Setting

Pre-hospital

Yes     No      Unclear

            

     
Emergency Department

Yes     No      Unclear

            

     
Operating Room

Yes     No      Unclear

            

     
Hospital Ward (non-intensive care setting)

Yes     No      Unclear

            

     
Paediatric Intensive Care UnitYes     No      Unclear                   
Neonatal Intensive Care UnitYes     No      Unclear                   
Other          
Inclusion criteria
Please list inclusion criteria specific to the study
          
Exclusion criteria
Please list exclusion criteria specific to the study
          
Method/s of recruitment of participants          

Informed consent obtained

 

Yes     No     Unclear           

 

How was this obtained? From whom?           
Notes:       

 

4.    Methods

 

 

Descriptions as stated in report/paper

 

Location in text

(pg & ¶/fig/table)

Aim of study

 

 

          

Design

Include how long patients were followed post intubation etc.

          

Blinding

Was there blinding in the study?

Yes     No     Unclear

            

 

     

Who was blinded?

 

 

Yes     No     Unclear

              Physicians

Yes     No     Unclear

              Nurses

Yes     No     Unclear

              Patients/ Patient’s family

Yes     No     Unclear

              Study Authors

Yes     No     Unclear

              Other      

     

 

 

 

 

Were patients randomized into separate treatment groups?

 

Yes     No     Unclear

              

 

     

Method of randomization

Please describe how the authors randomized patients

          

Start date listed?

 

Yes     No     Unclear

              Start date (dd/mm/yyyy)      

 

     

End date listed

 

Yes     No     Unclear

              Start date (dd/mm/yyyy)      

 

     

Total study duration

 

       # of days     
Ethical approval needed/ obtained for study

Yes     No     Unclear

              

     
Notes:      

5.    Risk of Bias assessment

 

Domain

Risk of bias

 

Support for judgement

 

Location in text

(pg & ¶/fig/table)

Low riskHigh riskUnclear
Random sequence generation              
Allocation concealment              

Blinding of participants and personnel

 

   

Outcome group: All/     

     

     
    

Outcome group:      

     

     

Blinding of outcome assessment

 

   

Outcome group: All/     

     

     
    

Outcome group:     

     

     
Incomplete outcome data              
Selective reporting              
Other bias              
Overall, the risk of bias is:              
Notes:       

 

6.    Participants

 

Description as stated in report/paper

 

Location in text

(pg & ¶/fig/table)

Total number randomized

 

 

          
Number of intervention groups, and associated number of participants per group          
Number of comparison groups, and associated number of participants per group          
Baseline imbalances between intervention and control group
List any significant differences between intervention and comparison group (Refer to table 1)
          

Withdrawals and exclusions intervention group

 

 

 

Yes     No     Unclear

              Excluded patients

# Excluded      

Reasons:      

 

Yes     No     Unclear

              Withdrawal from study

# Withdrawn      

Reasons:      

     

Withdrawals and exclusions comparison group 

 

 

 

Yes     No     Unclear

              Excluded patients

# Excluded      

Reasons:      

 

Yes     No     Unclear

              Withdrawal from study

# Withdrawn      

Reasons:      

     

7.    Intervention groups and Comparison Groups

Copy and paste table for each intervention and comparison group

 

Intervention Group #      

 

Description as stated in report/paper

 

Location in text

(pg & ¶/fig/table)

Group name

 

          

Number randomized to group

 

 

          

Age

Specificy age groups, including any premature infants

 

  
Infants > 28 days (1 month) – 12 months

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
1 year of age – 5 years of age

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
> 5 years of age

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
Other age group:      

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     

Sex

 

 

# Male      

# Female      

     

Setting

Pre-hospital

Yes     No     Unclear

              

# Included      

     
Emergency Department

Yes     No     Unclear

              

# Included      

     
Operating Room

Yes     No     Unclear

              

# Included      

     
Hospital Ward (non-intensive care setting)

Yes     No     Unclear

              

# Included      

     
Paediatric Intensive Care Unit

Yes     No     Unclear

              

# Included      

     
Neonatal Intensive Care Unit

Yes     No     Unclear

              

# Included      

     
Other:      

Yes     No     Unclear

              

# Included      

     

Indication for airway capture

 

Cardiac Arrest

Yes     No     Unclear

              

# Included      

     
Urgent surgery

Yes     No     Unclear

              

# Included      

     
Routine surgery

Yes     No     Unclear

              

# Included      

     
Poor secretion control/aspiration risk 

Yes     No     Unclear

              

# Included      

     
Failure to oxygenate

Yes     No     Unclear

              

# Included      

     

Failure to ventilate

 

Yes     No     Unclear

              

# Included      

     

Impending poor clinical course (ie: head injury)

 

Yes     No     Unclear

              

# Included      

     
Other :      

Yes     No     Unclear

              

# Included      

     

Level of training of operators involved

Staff/Attending physician

Yes     No     Unclear

              

# of intubations      

     
Resident/Intern (MD learner)

Yes     No     Unclear

              

# of intubations      

     
Medical Student

Yes     No     Unclear

              

# of intubations      

     
Respiratory Therapist

Yes     No     Unclear

              

# of intubations      

     
Physician Assistant

Yes     No     Unclear

              

# of intubations      

     
Anaesthesia Assistant

Yes     No     Unclear

              

# of intubations      

     
Other:       

Yes     No     Unclear

              

# of intubations      

     

Pre-Intubation care

 

Cardiac Monitoring

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Oxygen Saturation Monitoring

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Continuous Capnography

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Pre-oxygenation 

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients

     

Other treatment received

List all other treatments including other pre-medication agents

 

Benzodiazepines

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Ketamine

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Etomidate

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Propofol

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Narcotic agents

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Other sedative/hypnotic/analgesic

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Paralytic – Succinylcholine

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

 

     
Paralytic – Other

Yes     No     Unclear

              

Agent:       

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     

Atropine Delivery

 

Dose Used:       

Primiary indication for use:      

 

Multiple Doses Used?:        Indication for repeat dosing:      

     

Route

 

Intravenous

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug via this route

     
Oral

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug via this route

     
Intra-osseous

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug via this route

     
Other:      

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug via this route

     

Administered pre-intubation?

(ie: before passing tube)

 

 

Yes     No     Unclear

              

Comments/Details:      

     
Notes:  

 

Comparison Group #      

 

Description as stated in report/paper

 

Location in text

(pg & ¶/fig/table)

Group name

 

          

Number randomized to group

 

 

          

Age

Specificy age groups, including any premature infants

 

  
Infants > 28 days (1 month) – 12 months

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
1 year of age – 5 years of age

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
> 5 years of age

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     
Other age group:      

Yes     No     Unclear

              

# Included      

# ET Tube Placed      

     

Sex

 

 

# Male      

# Female      

     

Setting

Pre-hospital

Yes     No     Unclear

              

# Included      

     
Emergency Department

Yes     No     Unclear

              

# Included      

     
Operating Room

Yes     No     Unclear

              

# Included      

     
Hospital Ward (non-intensive care setting)

Yes     No     Unclear

              

# Included      

     
Paediatric Intensive Care Unit

Yes     No     Unclear

              

# Included      

     
Neonatal Intensive Care Unit

Yes     No     Unclear

              

# Included      

     
Other:      

Yes     No     Unclear

              

# Included      

     

Indication for airway capture

 

Cardiac arrest

 

Yes     No     Unclear

              

# Included      

     
Urgent surgery

Yes     No     Unclear

              

# Included      

     
Routine surgery

Yes     No     Unclear

              

# Included      

     
Poor secretion control/aspiration risk 

Yes     No     Unclear

              

# Included      

     
Failure to oxygenate

Yes     No     Unclear

              

# Included      

     

Failure to ventilate

 

Yes     No     Unclear

              

# Included      

     

Impending poor clinical course (ie: head injury)

 

Yes     No     Unclear

              

# Included      

     
Other :      

Yes     No     Unclear

              

# Included      

     

Level of training of operators involved

Staff/Attending physician

Yes     No     Unclear

              

# of intubations      

     
Resident/Intern (MD learner)

Yes     No     Unclear

              

# of intubations      

     
Medical Student

Yes     No     Unclear

              

# of intubations      

     
Respiratory Therapist

Yes     No     Unclear

              

# of intubations      

     
Physician Assistant

Yes     No     Unclear

              

# of intubations      

     
Anaesthesia Assistant

Yes     No     Unclear

              

# of intubations      

     
Other:       

Yes     No     Unclear

              

# of intubations      

     

Pre-Intubation care

 

Cardiac Monitoring

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Oxygen Saturation Monitoring

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Continuous Capnography

Yes     No     Unclear

              

          All patients? If no, then:

      # of patients

     
Pre-oxygenation 

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients

     

Other treatment received

List all other treatments including other pre-medication agents

 

Benzodiazepines

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Ketamine

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Etomidate

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Propofol

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Narcotic agents

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Other sedative/hypnotic/analgesic

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Agent:       

Dose Used:       

Multiple Doses Used?:        Indication:      

     
Paralytic – Succinylcholine

Yes     No     Unclear

              

          All patients in group? If no, then:

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

 

     
Paralytic – Other

Yes     No     Unclear

              

Agent:       

      # of patients receiving drug

Dose Used:       

Multiple Doses Used?:        Indication:      

     

NO Atropine Delivery Documented

 

Yes     No     Unclear

              

     
Notes:         

 

8.    Outcomes

 

Bradycardia        

Intervention Group

 

Notes

 

Location in text

(pg & ¶/fig/table)

Outcome definition or method of measurement          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences          
Method of documentation          
Person measuring/reporting          
Notes:      

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Age of patient :      

 >28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence  

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Bradycardia        

Comparison Group

 

Notes

 

Location in text

(pg & ¶/fig/table)

Outcome definition or method of measurement          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences          
Method of documentation          
Person measuring/reporting          
Notes:      

 

For each recorded adverse event, please complete the following:

Incidence number     
Patient identifier     
Nature of event/description     
Intervention required/description of response     
Age of patient :      

 >28 days – 12 months

 1 year – 5 years

 > 5 years

Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

Route of tube passage

 Orotracheal tube

 Nasotracheal tube

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

 

Tachycardia        

Intervention Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:      

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Duration of event          
Nature of event/description          
Intervention required/description of response          
Timing in intubation sequence (specifically state pre/post atropine)          
Minimum heart rate recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilation

 Required chest compressions

 Required pharmacologic agent:      

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Tachycardia        

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          

Notes:        

 

 

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Duration of event          
Nature of event/description          
Intervention required/description of response          
Timing in intubation sequence (specifically state pre/post atropine)          
Minimum heart rate recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilation

 Required chest compressions

 Required pharmacologic agent:      

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

Hypotension      

Intervention Group  

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:     

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Maximum heart rate recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilation

 Required cardioversion

 Required pharmacologic agent:      

 Other:      

     
Age of patient :      

 >28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Hypotension      

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Maximum heart rate recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilation

 Required cardioversion

 Required pharmacologic agent:      

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

Dysrhythmia      

Intervention Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:     

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Maximum blood pressure recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required antihypertensive agent

 Required other pharmacologic agent:      

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Dysrhythmia      

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:        

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Maximum blood pressure recorded          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required antihypertensive agent

 Required other pharmacologic agent:      

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

Hypoxia

Intervention Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:      

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Documented rhythm          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required vasopressor agent

 Required other pharmacologic agent:      

 Required vagal maneuvers

 Required cardioversion

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Hypoxia

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Documented rhythm          
Timing in intubation sequence (specifically state pre/post atropine)          
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required vasopressor agent

 Required other pharmacologic agent:      

 Required vagal maneuvers

 Required cardioversion

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

Emesis

Intervention Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Lowest documented oxygen saturation           
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilations 

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

Emesis

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Nature of event/description          
Intervention required/description of response          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Lowest documented oxygen saturation           
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Required bag mask ventilations 

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

> 1 Intubation Attempt 

Intervention Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Number of emesis            
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Suspected aspiration

 Required deep suctioning

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     
Route of atropine administration

 Intravenous

 Oral

 Intra-osseous

 Other:      

     

 

>1 Intubation Attempt

Comparison Group

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Outcome definitions and method of measurement (include unit of measurement)          
Is outcome/tool validated or sourced?

            

Yes      No     Unclear

     
Number of occurrences in group          
Number of benign occurrences in group          
Number of clinically significant occurrences in group          
Method of documentation          
Person measuring/reporting          
Notes:         

 

For each recorded adverse event, please complete the following:

Incidence number          
Patient identifier          
Duration of event          
Timing in intubation sequence (specifically state pre/post atropine)          
Number of emesis            
Associated clinical change

                                        

Benign            Significant

     
If clinically significant, why?

 Suspected aspiration

 Required deep suctioning

 Other:      

     
Age of patient :      

 > 28 days – 12 months

 1 year – 5 years

 > 5 years

     
Timing in intubation sequence 

 Pre-atropine

 Post atropine

Details:      

     
Setting of intubation procedure

 Pre-hospital

 Emergency Department

 Operating Room

 Hospital ward (non-intensive care setting)

 Paediatric Intensive Care Unit

 Neonatal Intensive Care Unit

 Other:      

     
Indication for intubation procedure

 Cardiac arrest

 Urgent surgery

 Routine surgery

 Poor secretion control/aspiration risk

 Failure to oxygenate

 Failure to ventilate

 Impending clinical course (Ie: head injury)

 Other:      

     
Route of tube passage

 Orotracheal tube

 Nasotracheal tube

     

Technique of intubation procedure

 

 STAT airway

 Rapid sequence induction

 Standard intubation  

     
Patient paralysed?

            

Yes     No

Agent used:             Multiple dose?:              

                                                                      Yes     No

     

 

9.    Results

Bradycardia

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Time          
Results Intervention Comparison     
No. eventsNo. participantsNo. eventsNo. participants
                    
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported          
Unit of analysis (by individuals, cluster/groups or body parts)           
Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:         

 

Tachycardia

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Timepoint          
Post-intervention or change from baseline?          
Results Intervention Comparison 
MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     
                              
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported           
Unit of analysis           
Statistical methods used and appropriateness of these methods          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:          

 

Tachycardia

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Timepoint          
Post-intervention or change from baseline?          
Results Intervention Comparison 
MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     
                              
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported           
Unit of analysis           
Statistical methods used and appropriateness of these methods          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:          

Hypotension

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Timepoint          
Post-intervention or change from baseline?          
Results Intervention Comparison 
MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     
                              
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported           
Unit of analysis           
Statistical methods used and appropriateness of these methods          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:    

Dysrhythmia

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Timepoint          
Post-intervention or change from baseline?          
Results Intervention Comparison 
MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     
                              
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported           
Unit of analysis           
Statistical methods used and appropriateness of these methods          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:          

 

Hypoxia 

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Time          
Results Intervention Comparison     
No. eventsNo. participantsNo. eventsNo. participants
                    
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported          
Unit of analysis (by individuals, cluster/groups or body parts)           
Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:         

 

Emesis

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Time          
Results Intervention Comparison     
No. eventsNo. participantsNo. eventsNo. participants
                    
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported          

Unit of analysis (by individuals, cluster/groups or body parts)

 

          
Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

            

Yes      No     Unclear

          
Reanalysed results          
Notes:         

 

>1 Intubation attempt

 

Description as stated in paper

 

Location in text

(pg & ¶/fig/table)

Comparison          
Outcome          
Subgroup          
Time          
Results Intervention Comparison     
No. eventsNo. participantsNo. eventsNo. participants
                    
No. missing participants and reasons               
No. participants moved from other group and reasons               
Any other results reported          
Unit of analysis (by individuals, cluster/groups or body parts)           
Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          
Reanalysis required?

            

Yes      No     Unclear

          
Reanalysis possible?

           

Yes      No     Unclear

         
Reanalysed results          
Notes:         

 

10. Applicability

 

Have important populations been excluded from the study?

           

Yes      No     Unclear

     

Does the study directly address the review question?

 

       

Yes      No     Unclear

     
Notes:         

 

11. Other information

 

 

Description as stated in report/paper

 

Location in text

(pg & ¶/fig/table)

Key conclusions of study authors           
References to other relevant studies           
Correspondence required for further study information     
Notes:         

 

 

Contributions of authors

Ashlea R Wilmott (AW), Graham C Thompson (GT), Eddy Lang (EL), Susan Powelson (SP), Abel Wakai (AbW), Ben Vandermeer (BV), Ronan O'Sullivan (ROS)

AW, the primary author, initially posed the research question that prompted this review and secured the necessary funding. AW received assistance from all listed co-authors (GT, EL, SP, AbW, BV, ROS).

GT is the primary author's core preceptor for this project, and assisted in authoring and editing the protocol.

EL contributed towards editing the protocol.

SP created the search strategy, authored the search methodology portion of this protocol, and generated the MEDLINE search terms.

BV co-authored and edited the statistics-based methodology portions of the protocol.

ROS and AbW served as mentors to the primary author.

Declarations of interest

Ashlea R Wilmott: the primary author of this review is a paid employee of Alberta Health Services, but this relationship has no influence on the conducting, analysis, or reporting of the review

Graham C Thompson: none known

Eddy Lang: none known

Susan Powelson: none known

Abel Wakai: none known

Ben Vandermeer: none known

Ronan O'Sullivan: none known

Sources of support

Internal sources

  • Emergency Medicine Research Advisory Committee, University of Calgary, Canada.

    Financial

External sources

  • No sources of support supplied

Ancillary