Intensive Care Medicine

, Volume 42, Issue 12, pp 1888–1898 | Cite as

Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA)

  • Emmanuel Futier
  • Catherine Paugam-Burtz
  • Thomas Godet
  • Linda Khoy-Ear
  • Sacha Rozencwajg
  • Jean-Marc Delay
  • Daniel Verzilli
  • Jeremie Dupuis
  • Gerald Chanques
  • Jean-Etienne Bazin
  • Jean-Michel Constantin
  • Bruno Pereira
  • Samir Jaber
  • OPERA study investigators
Original

Abstract

Purpose

High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap.

Methods

A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015).

Results

Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14–18 h) with standard oxygen therapy and 15 h (interquartile range 12–18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI –8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53–1.43; p = 0.58). Over the 7-day postoperative follow-up period, there was no statistically significant difference between the groups in the proportion of patients who remained free of any pulmonary complication (ARR 7, 95 % CI –6 to 20 %; p = 0.40). Other secondary outcomes also did not differ significantly between the two groups.

Conclusions

Among patients undergoing major abdominal surgery, early preventive application of high-flow nasal cannula oxygen therapy after extubation did not result in improved pulmonary outcomes compared with standard oxygen therapy.

Keywords

Postoperative hypoxaemia Oxygen therapy Postoperative pulmonary complications Perioperative medicine High-risk surgery 

Notes

Acknowledgments

The OPERA trial investigators would like to thank all patients who participated in the study, and the clinical and research coordinators at all participating sites, especially Dominique Morand (Direction de la Recherche Clinique, DRC, Clermont-Ferrand, France), Albert Prades (Montpellier University Hospital, Montpellier, France) as well as the nurses and medical staff at all of the participating sites, without whom the OPERA study would never have been completed.

Compliance with ethical standards

Conflicts of interest

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. EF reports receiving consulting fees from Fresenius kabi, and lecture fees from General Electrics Heathcare and Fresenius kabi, nonfinancial support from Drager, and reimbursement of travel expenses from Fisher and Paykel Healthcare. CPB reports receiving consulting fees from Merck Sharp & Dohme, Baxter Gambro and Astellas. TG reports receiving a research grant from LFB Bio-medicaments and meeting support (reimbursement of travel costs) from Baxter Gambro. SJ reports receiving consulting fees from Drager, Maquet, Hamilton and Fisher and Paykel Healthcare, lecture fees from Abbott and Philips, and reimbursement of travel expenses from Pfizer. The other authors declare no competing interests.

Supplementary material

134_2016_4594_MOESM1_ESM.pdf (1005 kb)
Supplementary material 1 (PDF 1005 kb)

References

  1. 1.
    Arozullah AM, Daley J, Henderson WG, Khuri SF (2000) Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg 232:242–253CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ, Investigators PN (2014) Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med 2:1007–1015CrossRefPubMedGoogle Scholar
  3. 3.
    Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ (2005) Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 242:326–341PubMedPubMedCentralGoogle Scholar
  4. 4.
    Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S (2013) A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med 369:428–437CrossRefPubMedGoogle Scholar
  5. 5.
    Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ, PROVE Network Investigators (2015) Protective versus conventional ventilation for surgery: a systematic review and individual patient data meta-analysis. Anesthesiology 123:66–78CrossRefPubMedGoogle Scholar
  6. 6.
    Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ (2014) High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet 384:495–503CrossRefPubMedGoogle Scholar
  7. 7.
    Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP (1996) Risk of pulmonary complications after elective abdominal surgery. Chest 110:744–750CrossRefPubMedGoogle Scholar
  8. 8.
    Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R, FLORALI Study Group, REVA Network (2015) High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med 372:2185–2196CrossRefPubMedGoogle Scholar
  9. 9.
    Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L, BiPOP Study Group (2015) High-flow nasal oxygen vs noninvasive positive airway pressure in hypoxemic patients after cardiothoracic surgery: a randomized clinical trial. JAMA 313:2331–2339CrossRefPubMedGoogle Scholar
  10. 10.
    Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R (2016) Effect of postextubation high-flow nasal cannula vs conventional oxygen therapy on reintubation in low-risk patients: a randomized clinical trial. JAMA 315:1354–1361CrossRefPubMedGoogle Scholar
  11. 11.
    Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E (2016) Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med 11:1–4Google Scholar
  12. 12.
    Spoletini G, Alotaibi M, Blasi F, Hill NS (2015) Heated humidified high-flow nasal oxygen in adults: mechanisms of action and clinical implications. Chest 148:253–261CrossRefPubMedGoogle Scholar
  13. 13.
    Futier E, Paugam-Burtz C, Constantin JM, Pereira B, Jaber S (2013) 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. Trials 14:341CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J (2010) Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology 113:1338–1350CrossRefPubMedGoogle Scholar
  15. 15.
    Popping DM, Elia N, Marret E, Remy C, Tramer MR (2008) Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg 143:990–999 (discussion 1000)CrossRefPubMedGoogle Scholar
  16. 16.
    Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM (2005) Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA 293:589–595CrossRefPubMedGoogle Scholar
  17. 17.
    Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL (2006) Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA 296:1851–1857CrossRefPubMedGoogle Scholar
  18. 18.
    Corley A, Bull T, Spooner AJ, Barnett AG, Fraser JF (2015) Direct extubation onto high-flow nasal cannulae post-cardiac surgery versus standard treatment in patients with a BMI ≥30: a randomised controlled trial. Intensive Care Med 41:887–894CrossRefPubMedGoogle Scholar
  19. 19.
    Parke R, McGuinness S, Dixon R, Jull A (2013) Open-label, phase II study of routine high-flow nasal oxygen therapy in cardiac surgical patients. Br J Anaesth 111:925–931CrossRefPubMedGoogle Scholar
  20. 20.
    Futier E, Marret E, Jaber S (2014) Perioperative positive pressure ventilation: an integrated approach to improve pulmonary care. Anesthesiology 121:400–408CrossRefPubMedGoogle Scholar
  21. 21.
    Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M (2014) Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med 190:282–288CrossRefPubMedGoogle Scholar
  22. 22.
    Parke RL, McGuinness SP (2013) Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care 58:1621–1624CrossRefPubMedGoogle Scholar
  23. 23.
    Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S (2013) Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol 79:1344–1355PubMedGoogle Scholar
  24. 24.
    Parke RL, Bloch A, McGuinness SP (2015) Effect of very-high-flow nasal therapy on airway pressure and end-expiratory lung impedance in healthy volunteers. Respir Care 60:1397–1403CrossRefPubMedGoogle Scholar
  25. 25.
    Yang D, Grant MC, Stone A, Wu CL, Wick EC (2016) A meta-analysis of intraoperative ventilation strategies to prevent pulmonary complications: is low tidal volume alone sufficient to protect healthy lungs? Ann Surg 263:881–887 Google Scholar
  26. 26.
    Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM (2007) Statistics in medicine—reporting of subgroup analyses in clinical trials. N Engl J Med 357:2189–2194CrossRefPubMedGoogle Scholar
  27. 27.
    Cabrini L, Landoni G, Oriani A, Plumari VP, Nobile L, Greco M, Pasin L, Beretta L, Zangrillo A (2015) Noninvasive ventilation and survival in acute care settings: a comprehensive systematic review and metaanalysis of randomized controlled trials. Crit Care Med 43:880–888CrossRefPubMedGoogle Scholar
  28. 28.
    Ireland CJ, Chapman TM, Mathew SF, Herbison GP, Zacharias M (2014) Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery. Cochrane Database Syst Rev 8:CD008930Google Scholar
  29. 29.
    Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De Jong A, Chanques G, Brochard L, Molinari N, NIVAS Study Group (2016) Effect of noninvasive ventilation on tracheal reintubation among patients with hypoxemic respiratory failure following abdominal surgery: a randomized clinical trial. JAMA 315:1345–1353CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2016

Authors and Affiliations

  • Emmanuel Futier
    • 1
    • 2
  • Catherine Paugam-Burtz
    • 3
  • Thomas Godet
    • 1
  • Linda Khoy-Ear
    • 3
  • Sacha Rozencwajg
    • 3
  • Jean-Marc Delay
    • 4
  • Daniel Verzilli
    • 4
  • Jeremie Dupuis
    • 1
  • Gerald Chanques
    • 4
    • 6
  • Jean-Etienne Bazin
    • 1
  • Jean-Michel Constantin
    • 1
    • 2
  • Bruno Pereira
    • 5
  • Samir Jaber
    • 4
    • 6
  • OPERA study investigators
  1. 1.CHU de Clermont-Ferrand, Pôle Médecine Périopératoire (MPO), Hôpital EstaingClermont-FerrandFrance
  2. 2.Laboratoire UniversitaireUniversité d’AuvergneClermont-FerrandFrance
  3. 3.AP-HP, Département Anesthésie-Réanimation, Hôpital BeaujonHôpitaux Universitaires Paris Nord Val de SeineParisFrance
  4. 4.CHU de Montpellier, Département Anesthésie Réanimation B (DAR B)Hôpital Saint EloiMontpellierFrance
  5. 5.CHU de Clermont-Ferrand, Direction de la Recherche Clinique (DRC)Clermont-FerrandFrance
  6. 6.University of Montpellier, INSERM U-1046MontpellierFrance

Personalised recommendations