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. 2013 Jul 31;2013(7):CD009082. doi: 10.1002/14651858.CD009082.pub2

Jouvet 2013.

Methods Single‐centre, randomized controlled trial
Participants Setting: pediatric ICU, Montreal, Canada
Inclusion criteria: age between 2 and 18 years; body weight ≥ 15 kg; mechanically ventilated > 12 hours; availability of Evita XL respirator with SmartCare/PSTM ; fulfilling weaning criteria (able to breathe spontaneously; no vasopressor or inotropic medication; FiO2 ≤ 60% with pulse oximetry ≥ 95%; PEEP ≤ 8 cm H2O; PaCO2 < 70 mmHg; endotracheal tube leakage ≤ 20%)
Exclusion criteria: chronic respiratory insufficiency due to neurological, neuromuscular or lung disease before ICU admission; primary pulmonary hypertension; cyanotic congenital heart disease with unrepaired/palliated right to left intracardiac shunt; not expected to survive; decision to withdraw care; no parental consent
Participant numbers: 30 randomly assigned; 30 analysed
Interventions
  • Automated weaning protocol using SmartCare/PS

  • Standard weaning practice without formal guidelines (detail not reported)

Outcomes
  • Time from randomization to first extubation

  • Weaning failure (resuming invasive or noninvasive mechanical ventilation within 48 hours)

  • Failure to wean within 28 days

  • Total duration of mechanical ventilation (from intubation to extubation)

  • ICU and hospital length of stay

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 30 sealed envelopes contained control or SmartCare group sheet of paper (15 each) in a random manner and numbered from 1 to 30. After inclusion of a participant, the research assistant took the envelope n°1, 2, etc (author communication)
Allocation concealment (selection bias) Low risk Opaque sealed envelopes were used
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Personnel were unblinded and extubation decision was made by attending clinicians in both groups
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk This was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Recruitment and attrition were reported
Selective reporting (reporting bias) Low risk Protocol was registered as NCT00678912 and outcomes were reported
Other bias Low risk None was apparent