Purpose: Postoperative pulmonary complications (PPCs) are a common cause of morbidity. Postoperative atelectasis is thought to be a significant risk factor in their development. Recent imaging studies suggest that patients' extubation may result in similar postoperative atelectasis regardless of the intraoperative mechanical ventilation strategy used. In this pilot trial, we hypothesized that a study investigating the effects of an open lung extubation strategy compared with a conventional one on PPCs would be feasible.
Methods: We conducted a pilot, single-centre, double-blinded randomized controlled trial. Adult patients at moderate to high risk of PPCs and scheduled for elective surgery were eligible. Patients were randomized to an open lung extubation strategy (semirecumbent position, fraction of inspired oxygen [FO] 50%, pressure support ventilation, unchanged positive end-expiratory pressure) or to a conventional extubation strategy (dorsal decubitus position, FO 100%, manual bag ventilation). The primary feasibility outcome was global protocol adherence while the primary exploratory efficacy outcome was PPCs.
Results: We randomized 35 patients to the conventional extubation group and 34 to the open lung extubation group. We observed a global protocol adherence of 96% (95% confidence interval, 88 to 99), which was not different between groups. Eight PPCs occurred (two in the conventional extubation group vs six in the open lung extubation group). Less postoperative supplemental oxygen and better lung aeration were observed in the open lung extubation group.
Conclusions: In this single-centre pilot trial, we observed excellent feasibility. A multicentre pilot trial comparing the effect of an open lung extubation strategy with that of a conventional extubation strategy on the occurrence of PPCs is feasible.
Study Registration Date: ClinicalTrials.gov (NCT04993001); registered 6 August 2021.
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