Walkey 2011.
Methods | Single centre randomized controlled trial | |
Participants | 33 adult patients (15 intervention; 18 control) receiving mechanical ventilation via an endotracheal tube for >48 hours Setting: USA, medical ICU |
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Interventions | Intervention: SmartCare/PS™ Control: weaning according to usual care |
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Outcomes | Duration of weaning assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation) Hospital mortality Complications (death during wean, ventilator‐associated pneumonia during wean, self extubation, reintubation) |
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Notes | This trial was terminated early due to slow recruitment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Online random number generator |
Allocation concealment (selection bias) | Low risk | Opaque envelopes used |
Incomplete outcome data (attrition bias) All outcomes | High risk | Study terminated early due to slow recruitment. Limited reporting of outcome data |
Selective reporting (reporting bias) | Unclear risk | Study terminated early due to slow recruitment. Limited reporting of outcome data |
Other bias | Unclear risk | Study terminated early due to slow recruitment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unable to confirm if outcome assessors were also involved in the daily care of patients |