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.

Abstract:

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.

journal_name

Trials

journal_title

Trials

authors

Futier E,Paugam-Burtz C,Constantin JM,Pereira B,Jaber S

doi

10.1186/1745-6215-14-341

subject

Has Abstract

pub_date

2013-10-18 00:00:00

pages

341

issn

1745-6215

pii

1745-6215-14-341

journal_volume

14

pub_type

杂志文章,多中心研究,随机对照试验

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