The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial
1 Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Teaching Hospital of Clermont-Ferrand, 1, place Lucie Aubrac, Clermont-Ferrand Cedex 1, 63000, France
2 Department of Anesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, Montpellier, 34295, France
3 Department of Anesthesiology and Critical Care Medicine, AP-HP Beaujon Hospital, 100, boulevard du Général Leclerc, Clichy, 92118, France
4 Biostatistics Unit, Direction de la Recherche Clinique (DRCI), 58 rue Montalembert, Clermont-Ferrand, 63003, France
Trials 2013, 14:341 doi:10.1186/1745-6215-14-341Published: 18 October 2013
Respiratory 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.
The 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.
The 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.
ClinicalTrials.gov Identifier: NCT01887015.