Published in:
Open Access 01-12-2013 | Study protocol
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
Published in: Trials | Issue 1/2013
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Background
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.
Methods/design
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.
Discussion
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.
Trial registration
ClinicalTrials.gov Identifier: NCT01887015