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Continuous versus intermittent physiological monitoring for acute stroke

  1. Alfonso Ciccone1,*,
  2. Maria Grazia Celani2,
  3. Raimondo Chiaramonte3,
  4. Cristiana Rossi4,
  5. Enrico Righetti4

Editorial Group: Cochrane Stroke Group

Published Online: 31 MAY 2013

Assessed as up-to-date: 13 AUG 2012

DOI: 10.1002/14651858.CD008444.pub2


How to Cite

Ciccone A, Celani MG, Chiaramonte R, Rossi C, Righetti E. Continuous versus intermittent physiological monitoring for acute stroke. Cochrane Database of Systematic Reviews 2013, Issue 5. Art. No.: CD008444. DOI: 10.1002/14651858.CD008444.pub2.

Author Information

  1. 1

    "Carlo Poma" Hospital, Department of Neurology and Stroke Unit, Mantua, Italy

  2. 2

    Azienda Ospedaliera Perugia, Neurofisiopatologia, Perugia, Umbria, Italy

  3. 3

    Rho Hospital, Emergency Department, A.O. "G. Salvini" - Garbagnate Milanese, Italy

  4. 4

    Ospedale di Città della Pieve, A USL 2 dell'Umbria, Stroke Unit, Città della Pieve, Italy

*Alfonso Ciccone, Department of Neurology and Stroke Unit, "Carlo Poma" Hospital, Strada Lago Paiolo 10, Mantua, 46100, Italy. alfonso.ciccone@aopoma.it.

Publication History

  1. Publication Status: New
  2. Published Online: 31 MAY 2013

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Characteristics of included studies [ordered by study ID]
Cavallini 2003

MethodsQuasi-randomised, open label controlled trial


ParticipantsFirst ever ischaemic stroke within 36 hours of onset


InterventionsContinuous monitoring of BP, ECG, OS, RF, BT, EEG on admission for at least 72 hours 

Conventional SU: intermittent monitoring (BP and HR every 4 hours during the first 3 days and 4 times a day thereafter); BT was measured 3 times a day; OS, RF, ECG on admission and in the event of adverse change in clinical conditions. The 2 groups were treated by the same multidisciplinary stroke team


OutcomesPrimary: mRS score of 0 to 3 (good outcome), mRS score 4 to 6, including death (poor outcome) at discharge


NotesTriggers of interventions: BP (triggers: systolic > 200 mmHg and/or diastolic >105 mmHg; systolic < 80 mmHg), ECG (trigger: new onset/worsening of arrhythmias, worsening of pre-existing cardiac disease, new changes, heart failure), BT: trigger > 37.8°C, OS: trigger < 91%. No mention of interventions for RF and EEG


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskPeople consecutively admitted to the cerebrovascular department were allocated to conventional SU or continuous monitoring purely on the basis of bed availability, with the SU beds always filled first

Allocation concealment (selection bias)High riskThe allocation of participants was the responsibility of the ward administrator, who was blind to the aims of the study

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData were extracted and analysed by an operator blind to the aims of the study but it was not specified whether outcome assessors were not blind to the allocation of participants

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll the randomised participants were accounted for in the analysis. We obtained data on length of stay, institutionalisation, and poor outcome (mRS > 3) from study authors

Selective reporting (reporting bias)Low riskNo

Other biasLow risk

Sulter 2003

MethodsPilot RCT, stratification for stroke subtype


ParticipantsIschaemic stroke within 24 hours of onset

Inclusion: age between 18 and 80 years, carotid artery territory, hemiparesis, consciousness preserved, ineligibility for intravenous thrombolysis

Exclusion: residual neurological impairment from a previous stroke, disorder interfering with neurological and functional assessment, life-threatening illness


InterventionsContinuous automated monitoring (Marquette Eagle 4000 monitors) for the first 48 hours and longer if required of ECG, BT (rectal thermometer), OS (pulse oximeter), BP (automatic non-invasive BP every 15 minutes), then standard care 

Conventional SU: intermittent monitoring (4 times day) of BT, HR, BP; OS determined when deemed necessary  


OutcomesPrimary: mRS score ≥ 4 or BI < 60 or institutional care and mortality at 3 months


NotesTriggerers of interventions: BP (triggers: systolic > 220 or mean BP > 130 mmHg; mean BP ≤ 80 mmHg), ECG (trigger: arrhythmias), BT (trigger > 37.5°C), OS (trigger < 95%), blood glucose (trigger > 10 mmol/L)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe random sequence generation was in a 1-to-1 manner

Allocation concealment (selection bias)Unclear riskAllocation by envelope system: it was not specified whether the envelopes were opaque and sealed

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo

Blinding of outcome assessment (detection bias)
All outcomes
Low riskA blinded observer assessed functional outcome at 3 months

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll the randomised participants were accounted for in the analysis

Selective reporting (reporting bias)Low riskNo

Other biasLow risk

VERITAS 2007

MethodsObserver-blinded, factorial (2 x 2) pilot RCT


ParticipantsIschaemic and haemorrhagic stroke within 24 hours of admission (and within 36 hours of stroke onset)

Inclusion: participant’s full consent

Exclusion: pre-stroke disability, full recovery, severe co-morbidities requiring close medical monitoring


Interventions(A) standard SU care; (B) early active mobilisation; (C) automated monitoring; (D) combined B + C

Automated monitoring: ambulatory monitoring (Welch Ally Inc.) of HR and heart rhythm, BP, BT, OS, blood glucose for the first 3 days (could be extended to 7 days if physiological variables were unstable), then standard care

Standard care: 4-hourly intermittent monitoring of pulse, BT, OS, BP

To assess automated monitoring C + D was compared with A + B


OutcomesPrimary: dead or disabled (mRS 4 to 5) at 3 months

Secondary (during the first 5 days after stroke): time to first mobilisation, best level of mobilisation activity achieved, number of physiological abnormalities recorded, early medical complications and adverse events, participant activity, neurological deterioration, Rivermead Mobility Index, walking speed, mRS, NIHSS, BI


NotesAbnormality of physiological variables (not specified whether the abnormalities detected were trigger of medical intervention): BP (systolic > 220 or < 110 mmHg, diastolic > 120 or < 70 mmHg), HR (pulse > 100 or < 50 bpm), OS (pO2 < 95%), BT (> 37.5°C), blood glucose (> 7 mmol)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe randomisation sequence was computer generated in blocks of 4

Allocation concealment (selection bias)Low riskAllocation by telephoning a secretary in an independent office who logged the participant and opened the next in a series of sequentially numbered opaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo

Blinding of outcome assessment (detection bias)
All outcomes
Low riskIndependent assessor blinded to treatment

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll the randomised participants were accounted for in the analysis

Selective reporting (reporting bias)Low riskNo

Other biasLow risk

 
Characteristics of excluded studies [ordered by year of study]

StudyReason for exclusion

Langhorne 2000Case-control study

Silva 2005Controlled but not randomised

Durastanti 2005Controlled but not randomised

Weber 2007Monitoring was tested in emergency flight rescue for less than 12 hours

Pappa 2009Controlled but not randomised

 
Characteristics of studies awaiting assessment [ordered by study ID]
Davis 2000

MethodsRCT

ParticipantsStroke within 24 hours of onset

InterventionsAugmented care (50 participants): 72 hours continuous physiological monitoring
Standard care (48 participants): 4-hourly observations

OutcomesNeurological deterioration in Scandinavian Stroke Scale on days 1, 2, 3, 7, 28 and 90

NotesNo full paper published. No data available on outcomes from abstracts. No response from authors

 
Characteristics of ongoing studies [ordered by study ID]
Higgins 2012

Trial name or titleEvaluation of electrocardiographic monitoring strategy to identify atrial fibrillation in patients with acute ischaemic stroke or TIA

MethodsMulticentre randomised controlled, open label trial

ParticipantsAcute ischaemic stroke or confirmed TIA within 1 week of symptom onset where an alternative cause for symptoms has been excluded

InterventionsNon-invasive cardiac event monitoring and 2 x 12-lead ECG versus standard investigation for AF

OutcomesStandard investigation, AF detection, anticoagulant therapy, adverse event detection

Starting date

Contact information

NotesRecruitment stopped but follow up is ongoing

Smith 2009

Trial name or titleLong-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)

MethodsRandomised controlled, open label trial
Pilot trial: 40 consecutive adults seen at the University of California at San Francisco Neurovascular service

ParticipantsAdults with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater) admitted at University of California Neurovascular service

InterventionsDischarged home with a portable outpatient cardiac telemetry device for 21 days versus discharged home with longitudinal standard clinical routine follow up

OutcomesPrimary outcome: feasibility, defined as more than 80% of randomised participants completing full clinical follow up and more than 70% of cardiac monitoring if applicable
Secondary outcomes: diagnosis of AF at 90 days and 1 year and diagnosis of recurrent stroke at 1 year

Starting date

Contact information

NotesOngoing but not recruiting

 
Comparison 1. Continuous monitoring versus intermittent monitoring of physiological variables

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Death or dependency by the end of scheduled follow up3354Odds Ratio (M-H, Random, 95% CI)0.27 [0.13, 0.56]

 2 Death at discharge3354Odds Ratio (M-H, Random, 95% CI)0.72 [0.28, 1.85]

 3 Dependency at three months or longer286Odds Ratio (M-H, Random, 95% CI)0.79 [0.30, 2.06]

 4 Death from vascular causes3354Odds Ratio (M-H, Random, 95% CI)0.48 [0.10, 2.39]

 5 Length of stay3354Mean Difference (IV, Random, 95% CI)-5.24 [-10.51, 0.03]

 6 Institutional care by the end of scheduled follow up2300Odds Ratio (M-H, Random, 95% CI)0.83 [0.04, 15.72]

 7 Neurological complications3354Odds Ratio (M-H, Random, 95% CI)0.81 [0.46, 1.43]

 8 Cardiac complications3354Odds Ratio (M-H, Random, 95% CI)8.65 [2.52, 29.66]

 9 Pneumonia3354Odds Ratio (M-H, Random, 95% CI)1.38 [0.54, 3.54]

 10 Other infections3354Odds Ratio (M-H, Random, 95% CI)2.11 [0.95, 4.66]

 11 Deep vein thrombosis2300Odds Ratio (M-H, Random, 95% CI)1.20 [0.33, 4.37]

 12 Fever3354Odds Ratio (M-H, Random, 95% CI)2.17 [1.27, 3.70]

 13 Hypoxia3354Odds Ratio (M-H, Random, 95% CI)2.25 [0.98, 5.18]

 14 Hypotension3354Odds Ratio (M-H, Random, 95% CI)4.92 [1.68, 14.39]

 15 Hypertension3354Odds Ratio (M-H, Random, 95% CI)2.02 [0.39, 10.39]