title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01887015.
authors.affiliation: 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. efutier@chu-clermontferrand.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Futier
authors.forename: Catherine
authors.initials: C
authors.lastname: Paugam-Burtz
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Constantin
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
mesh_terms: D000005:Abdomen / Q000601:surgery*; D060666:Airway Extubation; D002985:Clinical Protocols; D005602:France; D006801:Humans; D000860:Hypoxia / Q000209:etiology / Q000517:prevention & control*; D007442:Intubation, Intratracheal; D010102:Oxygen Inhalation Therapy / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome