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 |
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Interventions |
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Outcomes |
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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 |