Abstract
BackgroundRespiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation. High-flow nasal cannula oxygen (HFNC) delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. Whether application of HFNC may have therapeutic advantages over conventional oxygen therapy for respiratory support in the early postextubation surgical period remains to be established.Methods/designThe Optiflow for prevention of post-extubation hypoxemia after abdominal surgery (OPERA) trial is an investigator-initiated multicenter randomized controlled two-arm trial with assessor-blinded outcome assessment, randomizing 220 patients with intermediate to high risk of pulmonary complications after abdominal surgery to receive HFNC or conventional oxygen therapy following extubation, stratified by the presence of epidural analgesia and center. The primary outcome measure is the percentage of patients with postoperative hypoxemia one hour after tracheal extubation. Secondary outcome measures are postoperative pulmonary complications, need for noninvasive ventilation and intubation for respiratory failure.DiscussionThe OPERA trial is the first randomized controlled study powered to investigate whether early application of HFNC following extubation after abdominal surgery prevents against postoperative hypoxemia and pulmonary complications.Trial registrationClinicalTrials.gov Identifier: NCT01887015.
Highlights
Respiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation
The OPERA trial is the first randomized controlled study powered to investigate whether early application of High-flow nasal cannula oxygen (HFNC) following extubation after abdominal surgery prevents against postoperative hypoxemia and pulmonary complications
Trial interventions Patients eligible for inclusion following extubation after abdominal surgery are randomly assigned to standard oxygen therapy via either nasal prongs or face mask with oxygen flow titrated by the bedside clinician to maintain a peripheral oxygen saturation of 95% or more, or HFNC oxygen therapy at a flow rate of 50 to 60 L/min and FiO2 titrated by the bedside clinician to maintain a peripheral oxygen saturation of 95% or more
Summary
It has become clear that postoperative pulmonary complications are the main source of postoperative morbidity and mortality [2,22]. The OPERA trial is the first randomized controlled study powered to investigate early application of HFNC oxygen therapy in patients scheduled for abdominal surgery with intermediate to high risk of pulmonary complications. The ARISCAT score includes seven independent risk factors (four patient-related risk factors and three related to the surgical procedure, accounting for 55% and 45% of the score respectively), with the most relevant cut point being the risk score of 26 Several confounding factors, such as postoperative pain management, intraoperative fluid administration and respiratory chest physiotherapy, can be suggested. The OPERA trial is an investigatorinitiated pragmatic randomized controlled trial powered to test the hypothesis that early application of HFNC prevents postoperative hypoxemia in patients with intermediate to high risk of postoperative pulmonary complications.
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