Xi 2010.
Methods | Prospective, multi‐centre RCT | |
Participants | n = 110 Inclusion criteria
Exclusion criteria
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Interventions | Treatment: RM (CPAP 40 cm H2O for 40 seconds) performed 8‐hourly for first 5 days, unless weaning standard was reached Both groups: VT 6‐8 mL/kg; Pplat < 30 cmH2O; VCV or PCV for first 24 hours, with any mode thereafter; PEEP titrated to target PaO2 or FiO2 or both; permissive hypercapnia |
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Outcomes | Primary: ICU mortality Secondary: number of ventilator‐free days; non‐pulmonary organ dysfunction‐free days from day 1 to day 28; 28‐day mortality; percentage of unassisted breathing hours for at least 48 consecutive hours; incidence of barotrauma or pneumatocoele > 2 cm |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 15 participants were excluded for failure to follow the study protocol. |
Selective reporting (reporting bias) | Unclear risk | 15 participants were excluded for failure to follow the study protocol ‐ 3 in the control group and 12 in the intervention group (not analysed as intention‐to‐ treat). |
Intention to treat | High risk | 15 participants were excluded from final analysis for failure to adhere to study protocol. |