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A Randomized Controlled Trial

Vincenzo Squadrone, MD; Massimiliano Coha, MD; Elisabetta Cerutti, MD; Maria Maddalena Schellino, MD; Piera Biolino, MD; Paolo Occella, MD; Giuseppe Belloni, MD; Giuseppe Vilianis, MD; Gilberto Fiore, MD; Franco Cavallo, MD; V. Marco Ranieri, MD; for the Piedmont Intensive Care Units Network (PICUN)

JAMA. 2005;293:589-595.

Context  Hypoxemia complicates the recovery of 30% to 50% of patients after abdominal surgery; endotracheal intubation and mechanical ventilation may be required in 8% to 10% of cases, increasing morbidity and mortality and prolonging intensive care unit and hospital stay.

Objective  To determine the effectiveness of continuous positive airway pressure compared with standard treatment in preventing the need for intubation and mechanical ventilation in patients who develop acute hypoxemia after elective major abdominal surgery.

Design and Setting  Randomized, controlled, unblinded study with concealed allocation conducted between June 2002 and November 2003 at 15 intensive care units of the Piedmont Intensive Care Units Network in Italy.

Patients  Consecutive patients who developed severe hypoxemia after major elective abdominal surgery. The trial was stopped for efficacy after 209 patients had been enrolled.

Interventions  Patients were randomly assigned to receive oxygen (n = 104) or oxygen plus continuous positive airway pressure (n = 105).

Main Outcome Measures  The primary end point was incidence of endotracheal intubation; secondary end points were intensive care unit and hospital lengths of stay, incidence of pneumonia, infection and sepsis, and hospital mortality.

Results  Patients who received oxygen plus continuous positive airway pressure had a lower intubation rate (1% vs 10%; P = .005; relative risk [RR], 0.099; 95% confidence interval [CI], 0.01-0.76) and had a lower occurrence rate of pneumonia (2% vs 10%, RR, 0.19; 95% CI, 0.04-0.88; P = .02), infection (3% vs 10%, RR, 0.27; 95% CI, 0.07-0.94; P = .03), and sepsis (2% vs 9%; RR, 0.22; 95% CI, 0.04-0.99; P = .03) than did patients treated with oxygen alone. Patients who received oxygen plus continuous positive airway pressure also spent fewer mean (SD) days in the intensive care unit (1.4 [1.6] vs 2.6 [4.2], P = .09) than patients treated with oxygen alone. The treatments did not affect the mean (SD) days that patients spent in the hospital (15 [13] vs 17 [15], respectively; P = .10). None of those treated with oxygen plus continuous positive airway pressure died in the hospital while 3 deaths occurred among those treated with oxygen alone (P = .12).

Conclusion  Continuous positive airway pressure may decrease the incidence of endotracheal intubation and other severe complications in patients who develop hypoxemia after elective major abdominal surgery.

Author Affiliations: Dipartimento di Anestesia, Azienda Ospedaliera S.Giovanni Battista-Molinette, Università di Torino (Drs Squadrone, Coha, Cerutti, Schellino, Occella, and Ranieri), Servizio di Anestesia e Rianimazione, Ospedale Civile di Chivasso (Dr Biolino), Servizio di Anestesia e Rianimazione, Ospedale Civile di Ivrea (Dr Belloni), Servizio di Anestesia e Rianimazione, Ospedale Civile di Pinerolo (Dr Vilianis), Servizio di Anestesia e Rianimazione, Ospedale S. Croce di Monacalieri (Dr Fiore), and Dipartimento di Sanità Pubblica e Microbiologia, Università di Torino (Dr Cavallo), Italy.

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