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Original Investigation
Caring for the Critically Ill Patient
April 5, 2016

Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial

Author Affiliations
  • 1Saint Eloi University Hospital and Montpellier School of Medicine, Research Unit INSERM U1046, Montpellier, France
  • 2Saint Antoine Hospital, AP-HP, Paris, France
  • 3Estaing Hospital, Clermont-Ferrand, France
  • 4Beaujon Hospital, AP-HP, Paris, France
  • 5Rennes University Hospital, Rennes, France
  • 6Tours University Hospital, Tours, France
  • 7Angers University Hospital, Angers, France
  • 8Poitiers University Hospital, Poitiers, France
  • 9Edouard Herriot Hospital, Lyon, France
  • 10Institut Paoli Calmettes, Marseille, France
  • 11CHU Strasbourg, Strasbourg, France
  • 12Purpan Hospital, Toulouse, France
  • 13St Michael’s Hospital, Toronto, Ontario, Canada
  • 14Lapeyronie University Hospital and Montpellier School of Pharmacy, Research Unit IMAG U5149, Montpellier, France
JAMA. 2016;315(13):1345-1353. doi:10.1001/jama.2016.2706

Importance  It has not been established whether noninvasive ventilation (NIV) reduces the need for invasive mechanical ventilation in patients who develop hypoxemic acute respiratory failure after abdominal surgery.

Objective  To evaluate whether noninvasive ventilation improves outcomes among patients developing hypoxemic acute respiratory failure after abdominal surgery.

Design, Setting, and Participants  Multicenter, randomized, parallel-group clinical trial conducted between May 2013 and September 2014 in 20 French intensive care units among 293 patients who had undergone abdominal surgery and developed hypoxemic respiratory failure (partial oxygen pressure <60 mm Hg or oxygen saturation [Spo2] ≤90% when breathing room air or <80 mm Hg when breathing 15 L/min of oxygen, plus either [1] a respiratory rate above 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing) if it occurred within 7 days after surgical procedure.

Interventions  Patients were randomly assigned to receive standard oxygen therapy (up to 15 L/min to maintain Spo2 of 94% or higher) (n = 145) or NIV delivered via facial mask (inspiratory pressure support level, 5-15 cm H2O; positive end-expiratory pressure, 5-10 cm H2O; fraction of inspired oxygen titrated to maintain Spo2 ≥94%) (n = 148).

Main Outcomes and Measures  The primary outcome was tracheal reintubation for any cause within 7 days of randomization. Secondary outcomes were gas exchange, invasive ventilation–free days at day 30, health care–associated infections, and 90-day mortality.

Results  Among the 293 patients (mean age, 63.4 [SD, 13.8] years; n=224 men) included in the intention-to-treat analysis, reintubation occurred in 49 of 148 (33.1%) in the NIV group and in 66 of 145 (45.5%) in the standard oxygen therapy group within+ 7 days after randomization (absolute difference, −12.4%; 95% CI, −23.5% to −1.3%; P = .03). Noninvasive ventilation was associated with significantly more invasive ventilation–free days compared with standard oxygen therapy (25.4 vs 23.2 days; absolute difference, −2.2 days; 95% CI, −0.1 to 4.6 days; P = .04), while fewer patients developed health care–associated infections (43/137 [31.4%] vs 63/128 [49.2%]; absolute difference, −17.8%; 95% CI, −30.2% to −5.4%; P = .003). At 90 days, 22 of 148 patients (14.9%) in the NIV group and 31 of 144 (21.5%) in the standard oxygen therapy group had died (absolute difference, −6.5%; 95% CI, −16.0% to 3.0%; P = .15). There were no significant differences in gas exchange.

Conclusions and Relevance  Among patients with hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen therapy reduced the risk of tracheal reintubation within 7 days. These findings support use of NIV in this setting.

Trial Registration  clinicaltrials.gov Identifier: NCT01971892