Preoperative inspiratory muscle training for postoperative pulmonary complications in adult patients undergoing cardiac and major abdominal surgery

  • Protocol
  • Intervention

Authors


Abstract

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

Our primary objective is to compare the effectiveness of preoperative IMT and usual preoperative care on PPCs in adult patients undergoing cardiac or major abdominal surgery. We will look at the all-cause mortality and adverse events.

Our secondary objective is to investigate the effects of preoperative IMT on postoperative pulmonary functions, duration of hospital stay, and postoperative complications of other types. We will also evaluate the total drop-out, quality of life, and cost-effectiveness of preoperative IMT.

Background

Description of the condition

Despite advances in perioperative care in the last few decades, postoperative pulmonary complications (PPCs) are probably the leading cause of morbidity and mortality in patients undergoing chest and abdominal surgery. PPCs and cardiac complications are commonly regarded as representing the two major causes of perioperative problems in selected groups of patients undergoing these high-risk surgical procedures (Mendez-Tellez 2008). However, PPCs are more common than postoperative cardiac complications and play a bigger role in mortality and healthcare costs (Fleischmann 2003; Shander 2011; Smetana 2009). Despite these factors, the natural history of PPCs and the necessity of preventive strategies have not been well recognized in studies to date.

PPCs are comprised of atelectasis, pneumonia, bronchospasm, pleural effusion, pulmonary oedema, and respiratory failure (Brooks-Brunn 1995). Differences in the definition of PPCs across studies have contributed to a wide range in the reported incidences (6% to 76%) (Chumillas 1998). There are various changes in the respiratory system during the postoperative period that increase the risk of these complications, including consequences from the residual anaesthetic effect, the surgical procedure itself, and the effects of any premorbid conditions (Mendez-Tellez 2008).

A number of recognized risk factors predispose the patient to developing PPCs. These risk factors can be classified into procedure-related and patient-related risk factors (Mendez-Tellez 2008; Qaseem 2006). Procedure-related risk factors include the type of surgery (abdominal, thoracic, neuro, head and neck, vascular, aortic aneurysm repair, and emergency surgery are all associated with higher risk of PPCs), the site of incision, prolonged operative time (> three hours), and the type of anaesthesia (Guimarães 2009; Qaseem 2006; Smetana 2009). Patient-related risk factors include advanced age (≥ 60 years), pre-existing disease (e.g. chronic obstructive pulmonary disease (COPD), congestive heart failure), current smoking, alcohol consumption, functional dependence, impaired sensorium, recent marked weight loss, and American Society of Anesthesiologists (ASA) Physical Status (PS) Classification System class 2 (mild systemic disease without functional limitations) or severer status (Mendez-Tellez 2008; Qaseem 2006). It is important to consider these risk factors at the time of the preoperative evaluation.

Description of the intervention

Prevention of PPCs can be more effective than treatment of already established PPCs, and it is incumbent on the surgeon to assure that all necessary measures have been taken to prevent PPCs in their patient. For example, patients at high risk of PPCs who are scheduled to undergo elective surgery should be considered for preoperative respiratory rehabilitation strategies. These strategies can be performed in the outpatient setting (e.g. at home or in a local rehabilitation clinic) under the supervision of a physiotherapist. Hospitalized patients should also be commenced on a respiratory rehabilitation strategy immediately after surgery.

Respiratory rehabilitation is now considered to be the standard of care for surgical patients, the techniques of which include deep breathing exercises, thoracic physiotherapy, incentive spirometry (IS), and preoperative inspiratory muscle training (IMT; see Types of interventions). To date, there have been four systematic reviews that focused on IS for the prevention of PPCs after abdominal surgery (Guimarães 2009; Lawrence 2006; Overend 2001; Thomas 1994). The most recent review, which compared the effect of IS with no therapy or physiotherapy on PPCs, concluded that there is no evidence to support the effectiveness of IS for the prevention of PPCs after upper abdominal surgery (Guimarães 2009). More meticulous perioperative management is needed in high-risk patients, and therefore preoperative IMT has recently received wide research attention to prevent PPCs. (Hulzebos 2006b; Kulkarni 2010).

How the intervention might work

Respiratory muscle strength has not been reported to correlate with the routinely examined pulmonary function (e.g. vital capacity (VC), forced expired volume in one second (FEV1)) (Nomori 1994). However, patients with respiratory muscle weakness have a higher risk of PPCs (Nomori 1994). This is thought to be due to inspiratory muscle fatigue leading to collapse of alveoli (Kulkarni 2010). Several authors have reported that preoperative IMT resulted in significant improvement in mean inspiratory muscle strength and endurance after thoracic and abdominal surgery without causing adverse effects (Hulzebos 2006b; Kulkarni 2010; Nomori 1994). Thus, it is reasonable to assume that an increase in inspiratory muscle strength and endurance through preoperative IMT can lead to better quality deep breathing after surgery, which would then result in a decreased incidence of PPCs (Valkenet 2011).

In summary, preoperative IMT is a feasible intervention and seems to have a prophylactic effect against PPCs (Hulzebos 2006b; Valkenet 2011). These strategies to reduce PPCs can lead to improved perioperative patient care, better resource utilization, and overall cost savings (e.g. save extra invasive stresses and drugs, shorten the length of hospital stay and mechanical ventilation) for the public health system (Shander 2011).

Why it is important to do this review

PPCs affect the quality, effectiveness, and efficiency of postoperative patient care. It is, therefore, important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify patients who might benefit from respiratory rehabilitation.

Some published trials have demonstrated the advantages of preoperative IMT in patients undergoing cardiac surgery (Hulzebos 2006a; Hulzebos 2006b; Weiner 1998) or major abdominal surgery (Dronkers 2008; Kulkarni 2010). One systematic review summarized current evidence regarding the effectiveness of preoperative exercise therapy, including physical rehabilitation, on the postoperative complication rate in general (Valkenet 2011). However, to our knowledge no systematic review has focused on preoperative IMT itself for the prevention of PPCs. Thus, this systematic review will investigate whether preoperative IMT in patients undergoing cardiac or major abdominal surgery is an effective intervention for the prevention of PPCs. We hope that this review will help guide perioperative management in the future.

Objectives

Our primary objective is to compare the effectiveness of preoperative IMT and usual preoperative care on PPCs in adult patients undergoing cardiac or major abdominal surgery. We will look at the all-cause mortality and adverse events.

Our secondary objective is to investigate the effects of preoperative IMT on postoperative pulmonary functions, duration of hospital stay, and postoperative complications of other types. We will also evaluate the total drop-out, quality of life, and cost-effectiveness of preoperative IMT.

Methods

Criteria for considering studies for this review

Types of studies

We will include all randomized clinical trials (RCTs) that have compared preoperative intensive IMT and usual preoperative care for patients undergoing cardiac or major abdominal surgery. We will exclude quasi-randomized, historically controlled trials, cohort studies, and case series. However, we will include cluster-randomized trials if the intra-cluster correlation coefficient is reported.

Types of participants

We will include adult patients (≥ 18 years of age) awaiting elective cardiac or major abdominal surgery.

We define cardiac surgery as any surgical procedure involving the heart (e.g. coronary artery bypass graft surgery (CABG), valve surgery, and correction of congenital defects).

We define major abdominal surgery as deliberate breach of peritoneum or retroperitoneum, including abdominal aortic surgery, gastrointestinal surgery, and urological surgery.

We will exclude patients undergoing chest surgery that may involve the lung per se other than cardiac surgery because such procedures are bound to have a deep influence on pulmonary complications. We will also exclude patients if they have undergone surgery within two weeks of initial contact. We will exclude patients if they are ASA PS 5, or had suspected or established respiratory infection.

Types of interventions

The intervention will include a tailored training programme (called 'inspiratory muscle training' or IMT), which is designed to increase the strength and endurance of the inspiratory muscles. IMT consists of two distinct types of specific respiratory muscle training (i.e. respiratory muscle strength (resistive/threshold) and endurance (hyperpnoea) training). The training programme will consist of daily, six or seven times a week, training sessions for at least two weeks before the actual date of surgery. Each session will consist of 15 to 30 minutes of IMT, performed under supervision by either a physiotherapist, physician, or researcher. The subjects will be trained to use an inspiratory threshold-loading device with a load of 15% to 60% of maximal inspiratory muscle strength (Pi-max). In addition, the patients in the intervention group will receive usual care as defined below. We will exclude participants who also received IMT after the surgery.

Our comparative intervention will be usual care, a non-exercise intervention, or no intervention. The usual care group will receive care as usual the day before surgery (instruction on deep breathing manoeuvres, IS, coughing, and early mobilization may be provided). Both groups (control and intervention) therefore will receive similar IS, chest physiotherapy, and mobilization after surgery.

Types of outcome measures

Primary outcomes

1. Postoperative pulmonary complications (PPCs)

We define clinically significant PPCs as two or more items in the grade 2 complications or one item in the grade 3 or grade 4 complications (Appendix 1).

2. All-cause mortality within 30 days during postoperative period

3. Evidence of adverse events from IMT

Secondary outcomes

1. Maximal inspiratory muscle strength (Pi-max) and endurance (Pm-peak/Pi-max)

Inspiratory muscle strength and endurance will be assessed with respiratory pressure meter.

2. Duration of hospital stay

3. Other type of early complications within 30 days during postoperative period

  • Cardiac complications.

  • Neurological complications.

  • Surgical site infections (SSIs).

(see Appendix 2 about detail description of each complications)

4. Total drop-out from the study for any reason, as surrogate measure of overall acceptability

5. Quality of life (QoL)

Patient-reported health-related quality of life such as Short Form (SF)-12, SF-36, Health of the Nation Outcome Scales (HoNOS), and World Health Organization Quality of Life (WHO-QOL).

6. Cost analysis

Search methods for identification of studies

Electronic searches

We will contact the Trials Search Co-ordinator to search the Cochrane Anaesthesia Review Group's Trials Register. We will search the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, current issue) (Appendix 3), MEDLINE (Ovid SP, 1966 to date of search) (Appendix 4), EMBASE (Ovid SP, 1980 74 to date of search), CINAHL (EBSCO host, 1982 to date of search), LILACS (via BIREME, 1982 to date of search), and ISI Web of Science (1985 to date of search).

We will use a sensitive search strategy and search using both subject headings and free-text words. We will use search strategies that are optimal for identifying RCTs, together with specific subject terms. We will develop a search strategy for use in MEDLINE and revise it appropriately for use in all other databases in conjunction with the Cochrane Anaesthesia Review Group. We will use the cited and citing reference searching method in the Web of Science to find more recent articles that update earlier research. We will impose no language restrictions.

Searching other resources

We will check the reference lists of the included articles. We will identify trials and previous reviews by manually searching major related journals including Clinical Rehabilitation, Physiotherapy, and Physical Therapy since 1987. We will attempt to contact relevant trial authors or experts in the field to identify any additional on-going trials or unpublished data. We will search the conference proceedings of important meetings and abstracts. We will also search the databases of ongoing trials such as www.controlled-trials.com/ or www.clinicaltrials.gov/. We will contact companies who supply respiratory muscle training device, in order to identify possible ongoing trials.

Data collection and analysis

Selection of studies

Two review authors (MK and AK) will screen the titles and abstracts of all the publications obtained by the search strategy and will independently select trials that meet our inclusion criteria.

We will obtain the full text of all identified articles and any deemed unclear from the titles and abstracts. Two review authors (MK and AK) will independently examine the full-text articles to see if they meet the strict inclusion criteria. In case of disagreements, we will consult with a third independent review author (TT).

Data extraction and management

Two review authors (MK, AK) will independently and in duplicate extract data using a standardized form (Appendix 5), including the following information.

  1. Quality assessment of the study (risk of bias).

  2. Patients' characteristics.

  3. Intervention details and control agents.

  4. Outcomes (types of outcome measures, timing of outcomes, effect differences).

We will resolve any disagreement in consultation with the third review author (TT). We will collect data manually on paper extraction forms and enter it into intermediate software (Microsoft Excel for Windows), ensuring accurate transfer by using double entry, before being entered in Review Manager 5.1 (RevMan 2011). This will allow for any necessary statistical conversions.

Assessment of risk of bias in included studies

We will assess the risk of bias in the included studies using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Two review authors (MK, AK) will independently assess trial quality. We will report the degree of agreement between the two independent evaluators. A third review author (TT) will arbitrate and resolve any disagreements. This set of criteria is based on evidence of associations between effect overestimation and a high risk of bias in an article, such as random sequence generation, allocation concealment, blinding of participants and personnel, incomplete outcome data, selective reporting, and other bias. This will comprise a judgement for each specific feature of the study as low risk of bias, high risk of bias, or unclear risk of bias (unclear indicating either lack of information or uncertainty over the potential for bias). We will construct a 'Risk of bias' graph and 'Risk of bias' summary figure using RevMan (RevMan 2011).

Measures of treatment effect

We will perform all comparisons between the preoperative intensive IMT and usual preoperative care groups. We will use the following measures of the effect of intervention. We will calculate the risk ratio (RR) for dichotomous outcomes and the mean difference (MD; when all the outcomes are measured in the same unit) or standardized mean difference (SMD; when different measures are used to measure the same construct) for continuous outcomes.

Unit of analysis issues

We will take into account the level at which randomization occurred. We will make an assessment of the randomization into simple parallel groups and the variations of this such as cluster randomized trials. Two review authors (MK, AK) will review the unit of analysis issues according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve any differences by discussion. For trials that had a cross-over design, we will consider the results only from the first randomization periods. We will include cluster-randomized trials if the intra-cluster correlation coefficient is reported.

Dealing with missing data

We will take the following steps for handling any missing data:

  1. we will calculate the standard deviation (SD) from study statistics (e.g. 95% confidence intervals (CIs), standard errors, t values, P values, F values) for missing SDs of continuous outcome data;

  2. where possible, we will contact the original investigators of the study to obtain the missing data;

  3. we will address the potential impact of missing data on the findings of the review in the 'Discussion' section;

  4. when the exact SD calculation cannot be made, then we will impute them from other studies in the meta-analysis (Furukawa 2006). We will perform sensitivity analyses to assess how sensitive the results are to reasonable changes in the assumptions that are made.

For all outcomes, we will carry out analyses, as far as possible, on an intention-to-treat basis, that is, we will attempt to include all participants randomized to each group in the analyses, and analyse all participants in the group to which they were allocated, regardless of whether or not they received the allocated intervention. We will calculate and report the percentage lost to follow-up if there is a discrepancy in the numbers randomized and analysed in each treatment group. If there are drop-outs, we will look for reasons for drop-out in the publication itself or get further information from the authors of the publications as to the cause of the drop-outs. Then we will carry out analyses with knowledge of the precise outcomes because it is possible to make an informed guess about drop-outs. Finally, we will repeat meta-analysis imputing missing data and drop-outs as best and worst possible outcomes in a sensitivity analysis.

Assessment of heterogeneity

We will use clinical heterogeneity to describe differences in participants, interventions, and outcomes that might reasonably affect recruitment manoeuvres. We will initially assess heterogeneity by visual inspection of the results in the forest plots from a meta-analysis of the studies. We will measure statistical heterogeneity using the I2 and Q statistics (Higgins 2002; Higgins 2003). If significant heterogeneity is identified, (I2 ≥ 50% and P < 0.1), we will investigate potential sources through subgroup and sensitivity analysis. We will also undertake quality control checks of data extraction and input and review the clinical and methodological aspects of the study trials.

Assessment of reporting biases

If there are at least 10 trials in the meta-analysis, we will investigate reporting biases. Funnel plot asymmetry may be caused by: selection bias (publication or location bias), poor methodological quality of smaller studies (design, analysis, fraud), true heterogeneity (variation with effect size), or artefact or chance (Egger 1997). To assess the level of publication bias, we will perform a funnel plot analysis to make a visual assessment of whether small-study effects may be present in the meta-analysis (Egger 1997).

Data synthesis

If the trials are sufficiently homogeneous, and clinically similar trials are available, we will pool the results in the meta-analysis. We will pool data using the random-effects model for dichotomous and continuous data because the intervention in question represents a complex, variable method and statistical significance will be more conservative.

Dichotomous data

We will calculate the RR as an effect measure and its associated 95% CI because it is clinically interpretable and generalizable (Furukawa 2002). Where possible, we will calculate the number needed to treat for an additional beneficial outcome (NNTB) and its 95% CI, assuming the observed average control event rate.

Continuous data

We will calculate the MD and its associated 95% CI. We will use the SMD for data that we cannot convert to a uniform scale.

If no meta-analysis is possible or appropriate due to substantive clinical or statistical (or both) heterogeneity, skewed distribution, missing data or otherwise, we will qualitatively summarize and describe the identified studies.

Subgroup analysis and investigation of heterogeneity

We plan to perform the following subgroup analyses, where possible, by type of participants for the following a priori reasons:

  1. we will separately perform the analysis according to type of surgery, cardiac surgery, and major abdominal surgery as subgroup analysis, because the differences in operative procedure (procedure-related risk factors) may affect the postoperative status of the patients;

  2. we will perform the analysis among 'high-risk patients' because patient-related risk factors may affect the postoperative status of the patients. We will include high-risk patients if the trial reported the results of high-risk patients separately. If not, we will attempt to contact relevant trial authors to identify any additional unpublished data about patients' risk factors. We will also include the trials in which more than 80% of participants had at least one risk factor. However, we anticipate that various studies would have used variable definitions of 'high-risk patients'. We will accept these study authors' definitions;

  3. we will also perform the analysis according to the type of intervention and that of care in the control groups, respectively.

Sensitivity analysis

We will perform the following sensitivity analyses to check for the robustness of the observed findings. We will use Stata (Stata 11) to perform sensitivity analyses not available in RevMan (RevMan 2011).

  1. Repeating meta-analysis after exclusion of studies with unclear concealment of random allocation.

  2. Repeating meta-analysis after exclusion of studies in which the primary outcome evaluation was not blinded.

  3. Repeating meta-analysis imputing missing data and dropouts as best and worst possible outcomes.

  4. Comparing the difference of pooling analysis results by using a fixed-effect and a random-effects model.

  5. Repeating meta-analysis after exclusion of studies that do not use our definition but original authors' definition of PPCs.

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:

  • PPCs;

  • all-cause mortality within 30 days' postoperative period;

  • adverse events from intensive IMT;

  • duration of hospital stay;

  • other type of early postoperative complications (cardiac complications, neurological complications, SSIs);

in our review and construct a 'Summary of findings' (SoF) table. The GRADE approach assesses the quality of a body of evidence based on the extent to there can be confidence that an estimate of effect or association reflects the item being assessed. 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

We would like to thank Jane Cracknell (Managing Editor, Cochrane Anaesthesia Review Group (CARG)) and Karen Hovhannisyan (Trial Search Co-ordinator, CARG) for their help and editorial advice during the preparation of this protocol.

We would like to thank Mathew Zacharias (content editor), Cathal Walsh (statistical editor), Rik Gosselink, and Andrezza Lemos (peer reviewers) for their help and editorial advice during the preparation of this protocol for the systematic review.

Appendices

Appendix 1. Definition of postoperative pulmonary complications

GradeDefinition 
1Cough, dry 
 MicroatelectasisAbnormal lung findings and temperature > 37.5 °C without other documented cause; results of chest radiograph either normal or unavailable
 DyspnoeaNot due to other documented cause
2Cough, productiveNot due to other documented cause
 BronchospasmNew wheezing or pre-existing wheeze resulting in change in therapy
 HypoxaemiaAlveolar-arterial gradient > 29 and symptoms of dyspnoea or wheezing
 AtelectasisRadiological confirmation plus temperature > 37.5 °C or abnormal lung findings
 Hypercarbia, transientRequiring treatment, such as naloxone or increased manual or mechanical ventilation
 Adverse reaction to pulmonary medication 
3Pleural effusionResulting in thoracentesis
 Pneumonia, suspectedRadiological evidence without bacteriological confirmation
 Pneumonia, provedRadiological evidence and documentation of pathological organism by Gram stain or culture
 Pneumothorax 
 Re-intubationPostoperative or intubation, period of ventilator dependence does not exceed 48 hours
4Ventilatory failurePostoperative ventilator dependence exceeding 48 hours, or re-intubation with subsequent period of ventilator dependence exceeding 48 hours

We will define PPCs according to clinical (symptoms and physical examination) plus radiological criteria as atelectasis and pneumonia. When there are only radiological alterations, without clinical symptoms or alterations in auscultation, the complications will be considered to be subclinical, that is grade 1 PPCs (Chumillas 1998).

Many trials have employed different definition for PPCs because of difficulty of its measurement. We will use a valid and reliable definition according to Kroenke 1992. If the study authors use different definitions for pulmonary complications, we will contact the original authors to ascertain whether they have data available that matches our definition. If they do not, or if they fail to respond, we will use the original authors' definition for the moderate to severe complications. We will examine the influence of including such studies in a sensitivity analysis.

Appendix 2. Definition of postoperative complications

a) Cardiac complications

The cardiac complications were classified into the following categories (Wijeysundera 2009):

  1. myocardial infarction (MI): definition as per individual study;

  2. myocardial ischaemias: as detected on an electrocardiogram (ECG) or trans-oesophageal echocardiogram;

  3. supraventricular tachyarrhythmia (SVT): supraventricular tachycardia, atrial fibrillation, or atrial flutter;

  4. congestive heart failure (CHF): clinical diagnosis of CHF or a requirement for intra-aortic balloon pump support.

b) Neurological complications

The neurological complications were classified into two categories: type I neurological complications were defined as focal injury (e.g. stroke), stupor, or coma at discharge, while type II neurological complications were defined as deterioration in intellectual function, memory deficits, or seizures (Roach 1996).

c) Surgical site infections (SSIs)

We will use the criteria developed by The Centers for Disease Control and Prevention (CDC) for defining SSIs. These criteria define SSIs as infections related to the operative procedure that occurs at or near the surgical incision within 30 days of an operative procedure or within one year if an implant is left in place (Horan 1992).

Appendix 3. Search strategy for CENTRAL

#1 (Preoperative near ((inspiratory or muscle) and train*)) or IMT:ti,ab or (inspiratory and muscle and train*) or physiotherapy:ti,ab or ((presurgical or perioperative or preoperative) near train*):ti,ab or preconditioning

#2 MeSH descriptor Breathing Exercises explode all trees

#3 MeSH descriptor Physical Therapy Modalities, this term only

#4 MeSH descriptor Preoperative Care, this term only

#5 (#1 OR #2 OR #3 OR #4)

#6 (postoperative pulmonary complication*) or ((cardiac or valve or aort* or gastrointestinal or urological) near (surg* or operat*)):ti,ab or CABG or (correct* near (congenital defect*))

#7 MeSH descriptor Cardiac Surgical Procedures, this term only

#8 MeSH descriptor Coronary Artery Bypass, this term only

#9 MeSH descriptor Digestive System Surgical Procedures, this term only

#10 MeSH descriptor Urologic Surgical Procedures, this term only

#11 (#6 OR #7 OR #8 OR #9 OR #10)

#12 (#5 AND #11)

Appendix 4. Search strategy for MEDLINE (Ovid SP)

1. (Preoperative adj3 ((inspiratory or muscle) and train*)).af. or IMT.ti,ab. or (inspiratory and muscle and train*).af. or exp Breathing Exercises/ or Physical Therapy Modalities/ or Preoperative Care/ or physiotherapy.ti,ab. or ((presurgical or perioperative or preoperative) adj3 train*).ti,ab. or preconditioning.mp.

2. postoperative pulmonary complication*.mp. or Cardiac Surgical Procedures/ or ((cardiac or valve or aort* or gastrointestinal or urological) adj3 (surg* or operat*)).ti,ab. or Coronary Artery Bypass/ or CABG.mp. or (correct* adj3 congenital defect*).mp. or Digestive System Surgical Procedures/ or Urologic Surgical Procedures/

3. 1 and 2

4. ((randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti.) not (animals not (humans and animals)).sh.

5. 3 and 4

Appendix 5. Data extraction form

GENERAL INFORMATION

Date form completed (dd/mm/yyyy)     
Name/ID of person extracting data

     

 

Report title

(title of paper/ abstract/ report that data are extracted from)

     

 

Report ID

(ID for this paper/ abstract/ report)

     

 

Reference details

 

     

 

Report author contact details

     

 

Publication type

(e.g. full report, abstract, letter)

     

 

Study funding sources

(including role of funders)

     

 

Possible conflicts of interest

(for study authors)

     

 

Study Eligibility

Study Characteristics

Eligibility criteria

(We will include all randomized clinical trials that have compared preoperative intensive IMT and usual preoperative care for patients undergoing cardiac or major abdominal surgery. Quasi-randomized, historically controlled trials, cohort studies, and case series will be excluded. Cross-over trials will be excluded, but we will include cluster-randomized trials if the intra-cluster correlation coefficient is reported)

 

 

Yes

NoUnclearLocation in text
Type of studyRandomized controlled trial        
Quasi-randomized trial        

Type of study

 

Crossover study        
Cluster-randomized study        

Type of study

 

Single-centre study        
Multicentre study        

Participants

 

     

 

        
Types of intervention

     

 

        
Types of outcome measures

     

 

        
INCLUDE EXCLUDE 
Reason for exclusion     
        

Quality Assessment

DomainRisk of bias

Support for judgement

 

Location in text

 

Low riskHigh riskUnclear

Random sequence generation

(selection bias)

             

Allocation concealment

(selection bias)

             

Blinding of participants and personnel

(performance bias)

   

Outcome group: All/     

     

     

Blinding of outcome assessment

(detection bias)

   

Outcome group: All/     

     

     

Incomplete outcome data

(attrition bias)

             

Selective outcome reporting?

(reporting bias)

             
Other bias             

POPULATION AND SETTING

 

Description

Include comparative information for each group (i.e. intervention and controls) if available

Location in text

 

Population description

(from which study participants are drawn)

          

Setting

(including location and social context)

          
Setting of operation (procedure-related risk factors)

A: Cardiac surgery patients

B: Major abdominal surgery patients

C: Both cardiac and abdominal surgery patients

D: Other [     ]

     
Inclusion criteriaWe will include adult patients (≥ 18 years of age) awaiting elective cardiac or major abdominal surgery, that is with procedure-related risk factors. Cardiac surgery is defined as any surgical procedure involving the heart (e.g. coronary artery bypass graft surgery (CABG), valve surgery and correction of congenital defects). Major abdominal surgery is defined as deliberate breach of peritoneum, including abdominal aortic surgery, gastrointestinal surgery and urological surgery     
Exclusion criteria

 Chest surgery that may involving the lung

 Surgery performed within 2 weeks of initial contact

 ASA – PS5

 Other [       ]

     
Method/s of recruitment of participants          

Informed consent obtained

 

        

Yes   No        Unclear

          
    

METHODS

 Descriptions as stated in report/paperLocation in text
Aim of study          
Design (e.g. parallel, cross-over, cluster)          

Unit of allocation

(by individuals, cluster/ groups or body parts)

          
Start date          
End date          
Total study duration          
Ethical approval needed/ obtained for study

        

Yes   No   Unclear

          
    

PARTICIPANTS

 

Description as stated in report/paper

 

Location in text

Total no. randomized

(or total pop. at start of study for NRCTs)

          

Clusters

(if applicable, no., type, no. people per cluster)

          
Baseline imbalances          

Withdrawals and exclusions

(if not provided below by outcome)

          

Include high risk patient?

 

        

Yes   No   Unclear

 

 Our definition

 Study authors' definition

 

Number of high risk patients  [       ]

 

[Our definition]

We define 'high-risk patients' as patients with at least 1 of the following risk factors: advanced age (≥ 60 years), pre-existing disease (e.g. chronic obstructive pulmonary disease (COPD), congestive heart failure), current smoking, alcohol consumption, functional dependence, impaired sensorium, recent marked weight loss, and ASA class II or greater status

     
Patient-related risk factors   Ageadvanced age [age >    ] Number of patients  [       ]

Patient-related risk factors

Pre-existing disease and others

 

 COPD 

 current smoking [       ]

 alcohol use [       ]

 congestive heart failure

 functional dependence

 impaired sensorium

 recent marked weight loss[       ],

Number of patients  [       ]

Patient-related risk factors

According to ASA-PS

ASA-PS1 ASA-PS2 ASA-PS3 ASA-PS4 

ASA-PS5

Number of patients  [       ]
Sex          
Race/ethnicity          
Other treatment received          
Other relevant sociodemographics          
Subgroups measured          
Subgroups reported          

INTERVENTION DETAILS

[Intensive respiratory muscle training]

 Description as stated in report/paperLocation in text
Group nameIntervention type A [      ]     

No. randomized to group

(specify whether no. people or clusters)

          
Theoretical basis (include key references)          
Description (include sufficient detail for replication, e.g. content, dose, components)          
Duration of intervention period

for at least  [     ] weeks, each session

last  [     ] minutes

     
Frequency

A: Daily

B: [     ] times / week

C: unclear.

     
Place

A: at home     [     ] times /week

B: at local rehabilitation clinics

[     ] times /week

C: at hospital    [     ] times /week

D unclear

     
Intensity (device)

A: Inspiratory threshold-loading device

B: Other  [     ]  

 

The patients started breathing at a resistance equal to [     ]% of their maximal inspiratory mouth pressure

for  [     ] minutes.

 

The inspiratory load can be increased incrementally

     
Providers (Instructor)

[     ] session/week was supervised by

A: physical therapist

B: researcher

C: physician

D: other [     ] 

     
Co-interventions          
Economic variables
(i.e. intervention cost, changes in other costs as result of intervention)
          

Resource requirements to replicate intervention

(e.g. staff numbers, cold chain, equipment)

          
More than two types of intervention

Intervention type B [      ]                    [     ]

Intervention type C [      ]

     

CONTROL AGENTS

 Content of controlYesNoUnclearNote
Control agentsNo intervention        

Usual care

[                                                                     ]

[     ] day before surgery.

        

OUTCOMES

Outcome 1 (Copy and paste table for each outcome)

 Description as stated in report/paperLocation in text

Outcome name

 

          
Time points measured          
Time points reported          

Outcome definition

  (with diagnostic criteria if relevant)

          
Person measuring/reporting          

Unit of measurement

(if relevant)

          
Scales: upper and lower limits (indicate whether high  or low score is good)          
Is outcome/tool validated?

        

Yes   No   Unclear

          
Imputation of missing data
(e.g. assumptions made for ITT analysis)
          

Assumed risk estimate

(e.g. baseline or population risk noted  in Background)

          
Power          
    

 

RESULTS

< PRIMARY OUTCOMES >

Dichotomous outcomes

1.     Postoperative pulmonary complications (PPCs)

PPCs

 

 Our definition

 Study authors' definition

[Our definition]

A: Grade 1

B: Grade 2

C: Grade 3

D: Grade 4

[Authors’ definition]

a: Pneumonia  

b: Atelectasis  

c: Other [     ] 

     

 

2.     All-cause mortality within 30 days during postoperative period

 Copy and paste the appropriate table for each outcome, including additional tables for each time point and subgroup as required.

 Description as stated in report/paperLocation in text
Comparison          
Outcome          
Subgroup          
Timepoint
(specify whether from start or end of intervention)
          
ResultsInterventionComparison     
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)          
Re-analysis required? (specify)

        

Yes   No   Unclear

          
Re-analysis possible?

        

Yes   No   Unclear

          
Re-analysed results          
       

*Note: add additional columns if there is more than one intervention group, e.g. Intervention Type B, Intervention Type C…

 

3.     Adverse events from IMT

NOTE

[               ]

 

< SECONDARY OUTCOME >

Continuous outcomes

1.     Maximal inspiratory muscle strength (Pi-max) and endurance (Pm-peak/Pi-max).

2.     Duration of hospital stay

 

Description as stated in report/paper

 

Location in text
Comparison          
Outcome          
Subgroup          
Timepoint
(specify whether from start or end of intervention)
          
Post-intervention or change from baseline?          
ResultsInterventionComparison 
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

(individuals, cluster/ groups or body parts)

          
Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          
Re-analysis required? (specify)

        

Yes   No   Unclear

          
Re-analysis possible?

        

Yes   No   Unclear

          
Re-analysed results          
           

*Note: add additional columns if there is more than one intervention group, e.g.. Intervention Type B, Intervention Type C…

 

3.     Other type of early non-cardiac complications in the postoperative period

a) Cardiac complications   Yes   No    Unknown

  • MI

  • Myocardial ischaemia

  • SVT

  • CHF

b) Neurological complication   Yes   No    Unknown

  • Type I 

  • Type II

c) Surgical site infection    Yes   No    Unknown

  • Superficial incisional SSI

  • Deep incisional SSI

 

4.     Total drop-out from the study

 

Control

 

Intervention

(Type A)

Intervention

(Type B)

Intervention

(Type C)

Total number of all allocated patients[     ][     ][     ][     ]
Total drop-out[     ][     ][     ][     ]
due to [     ][     ][     ][     ][     ]
due to [     ][     ][     ][     ][     ]
due to [     ][     ][     ][     ][     ]
Total number of patients experiencing at least some side effects[     ][     ][     ][     ]

 

5.     Quality of life

Patient-reported health-related QOL :  SF-12 SF-36 HoNOS WHO-QOL

Control

 

Intervention

(Type A)

Intervention

(Type B)

Intervention

(Type C)

Baseline

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Between 1 and 4 weeks : at [     ] week from the start time point of treatment.

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Between 6 and 12 weeks : at [     ]week from the start time point of treatment.

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Between 4 and 6 months : at [     ] week/month from the start time point of treatment.

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

ENDPOINT : at [     ] week. If the data at original study endpoint are not mentioned so far, fill-in the blanks here.

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

Mean         [     ]

SD             [     ]

No. of patients              [     ]

 

6. Cost analysis

 

Control

 

Intervention

(Type A)

Intervention

(Type B)

Intervention

(Type C)

                    

APPLICABILITY

Have important populations been excluded from the study? (consider disadvantaged populations, and possible differences in the intervention effect)

        

Yes   No   Unclear

     

Is the intervention likely to be aimed at disadvantaged groups?

(e.g. lower socioeconomic groups)

        

Yes   No   Unclear

     

Does the study directly address the review question?

(any issues of partial or indirect applicability)

        

Yes   No   Unclear

     

OTHER INFORMATION

 Description as stated in report/paperLocation in text
Key conclusions of study authors          
References to other relevant studies          

Correspondence required for further study information

(from whom, what and when)

     

Contributions of authors

Conceiving the review: Morihiro Katsura (MK)

Designing the review: MK, Toshi A Furukawa (TAF)

Co-ordinating the review: MK

Undertaking manual searches: MK, Taro Takeshima (TT), Akira Kuriyama (AK)

Screening search results: MK, TT, AK

Organizing retrieval of papers: Shunichi Fukuhara (SF), TAF

Screening retrieved papers against inclusion criteria: MK, TT, AK

Appraising quality of papers: SF, TAF

Abstracting data from papers: MK, TT, AK

Writing to authors of papers for additional information: MK, AK

Providing additional data about papers: TT, AK

Obtaining and screening data on unpublished studies: MK, TT, AK

Data management for the review: MK, AK

Entering data into RevMan (RevMan 2011): MK, AK

RevMan statistical data: MK, AK, TAF

Other statistical analysis not using RevMan: MK, AK, TAF

Double entry of data: (data entered by person one: MK; data entered by person two: AK)

Interpretation of data: MK, TT, AK, SF, TAF

Statistical inferences: TAF

Writing the review: MK, AK, TAF

Providing guidance on the review: TAF

Securing funding for the review: not applicable

Performing previous work that was the foundation of the present study: MK, TAF

Guarantor for the review (one author): MK

Person responsible for reading and checking review before submission: MK, SF, TAF

Declarations of interest

Morihiro Katsura: none known.

Akira Kuriyama: none known.

Taro Takeshima: none known.

Shunichi Fukuhara: none known.

Toshi A Furukawa: TAF has received honoraria for speaking at CME meetings sponsored by Asahi Kasei, Eli Lilly, GlaxoSmithKline, Kyorin, Meiji, Mochida, MSD, Otsuka, Pfizer, Shionogi, and Tanabe-Mitsubishi. He is on advisory board for Pharmaceuticals and Medical Devices Agency, Sekisui Chemicals and Takeda Science Foundation. He has received royalties from Igaku-Shoin, Seiwa-Shoten, and Nihon Bunka Kagaku-sha. He is on the advisory board for Sekisui Chemicals and Takeda Science Foundation

Sources of support

Internal sources

  • New Source of support, Not specified.

External sources

  • New Source of support, Not specified.

Ancillary