Stahl 2009.
| Methods | ||
| Participants | Age 18 to 80 years Body weight between 35 kg and 200 kg Invasively mechanical ventilated via endotracheal tube or tracheostomy for ≥ 24 hours Ramsey Score ≤ 3 Spontaneous breathing mode with PEEP ≤ 10 Sufficient arterial oxygenation with PaO2 > 55 mmHg/75 cm H2O or SaO2 > 90% on FiO2 ≤ 0.50. Haemodynamically stable (dopamine < 5 mcg/kg/min) Rectal temperature ≤ 39°C Haemoglobin ≥ 70 g/L pH > 7.20 |
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| Interventions | ||
| Outcomes | Time to successful extubation Total duration of mechanical ventilation (from initiation to extubation) Time from initiation to randomization Time to reintubation Length of ICU stay Clinician workload (physician changes in ventilator settings, FiO2, PEEP and nurses' cleaning of cuvette) ICU mortality Hospital mortality Adverse event: reintubation Proportion successfully extubated |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Study authors used a computer‐generated randomization system (Rita software (version 1.13a)) |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque, sequentially numbered envelopes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Individuals assessing outcomes were not separate from individuals supervising or administering study interventions |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | First 10 participants who failed an initial attempt at weaning were discontinued from the study. The protocol was subsequently modified to permit a second weaning attempt. Dropouts occurred with similar frequency between study groups (4 per group) post randomization (8/60 (13.3%)), and their outcomes were included in the analyses when possible. These 8 participants could not be extubated. The first 10 participants who failed an attempt at weaning were included in the final analyses |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Did the trial stop early for benefit? | Low risk | Stopped early for futility after 60 of 108 planned participants were enrolled |
| Participants analysed according to the group allocated to? | Low risk | Yes, study authors adhered to the intention‐to‐treat principle |