Choi 2006.
Methods | RCT with parallel groups Approved by the Medical Ethics Committee of the University of Amsterdam (Amsterdam, The Netherlands), and informed consents obtained from all participants Site: Academic Medical Center, University of Amsterdam, The Netherlands Setting: university hospital Dates of data collection: December 2003 to March 2005 |
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Participants | 46 adults scheduled to undergo a surgical procedure of ≥ 5 hours Exclusion criteria: history of any lung disease, use of immunosuppressive medication, recent infections, previous thromboembolic disease or recent admission to ICU for ventilatory support |
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Interventions |
Treatment group: tidal volume 6 mL/kg (IBW) and PEEP 10 cmH2O (n = 24 randomized; n = 21 analysed) Control group: tidal volume 12 mL/kg (IBW) and no PEEP (n = 22 randomized; and n = 19 analysed) The ventilatory protocol consisted of volume‐controlled mechanical ventilation at an FiO2 of 0.4, inspiratory/expiratory ratio of 1:2 and a respiratory rate adjusted to normocapnia. If the surgical procedure exceeded 5 hours, anaesthesiologists were allowed to change the ventilation strategy |
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Outcomes |
Relevant to this review
Others
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Notes | Funding: support provided solely from institutional or departmental sources (or both) Declaration of interest: none mentioned Participants were followed up until hospital discharge or death Volume per body weight: predicted body weight calculated based on the equation used by the ARDS Network in their clinical trials: predicted body weight of men: equal to 50 + 0.91 (centimetres of height – 152.4); women: equal to 45.5 + 0.91 (centimetres of height – 152.4) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed by drawing a presealed envelope." |
Allocation concealment (selection bias) | Low risk | Quote: "randomization was performed by drawing a presealed envelope." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for and low rate of dropout |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced Not intention‐to‐treat: quote: "five patients were randomized but excluded from final analysis, because the initial surgical procedure was converted by the surgeon into another shorter operation (< 3 hours). One patient was randomized, but no lavages were performed upon the surgeon's request after induction of anaesthesia." |