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The PROXI Randomized Clinical Trial

Christian S. Meyhoff, MD, PhD; Jørn Wetterslev, MD, PhD; Lars N. Jorgensen, MD, DMSc; Steen W. Henneberg, MD, DMSc; Claus Høgdall, MD, DMSc; Lene Lundvall, MD; Poul-Erik Svendsen, MD; Hannah Mollerup, MD; Troels H. Lunn, MD; Inger Simonsen, MD; Kristian R. Martinsen, MD; Therese Pulawska, MD; Lars Bundgaard, MD; Lasse Bugge, MD; Egon G. Hansen, MD; Claus Riber, MD; Peter Gocht-Jensen, MD; Line R. Walker, MD; Asger Bendtsen, MD; Gun Johansson, MD; Nina Skovgaard, MD; Kim Heltø, MD; Andrei Poukinski, MD; André Korshin, MD; Aqil Walli, MD; Mustafa Bulut, MD; Palle S. Carlsson, MD, DMSc; Svein A. Rodt, MD, DMSc; Liselotte B. Lundbech, MD; Henrik Rask, MD; Niels Buch, MD; Sharafaden K. Perdawid, MD; Joan Reza, MD; Kirsten V. Jensen, MD; Charlotte G. Carlsen, MD; Frank S. Jensen, MD, PhD; Lars S. Rasmussen, MD, PhD, DMSc; for the PROXI Trial Group

JAMA. 2009;302(14):1543-1550.

Context  Use of 80% oxygen during surgery has been suggested to reduce the risk of surgical wound infections, but this effect has not been consistently identified. The effect of 80% oxygen on pulmonary complications has not been well defined.

Objective  To assess whether use of 80% oxygen reduces the frequency of surgical site infection without increasing the frequency of pulmonary complications in patients undergoing abdominal surgery.

Design, Setting, and Patients  The PROXI trial, a patient- and observer-blinded randomized clinical trial conducted in 14 Danish hospitals between October 2006 and October 2008 among 1400 patients undergoing acute or elective laparotomy.

Interventions  Patients were randomly assigned to receive either 80% or 30% oxygen during and for 2 hours after surgery.

Main Outcome Measures  Surgical site infection within 14 days, defined according to the Centers for Disease Control and Prevention. Secondary outcomes included atelectasis, pneumonia, respiratory failure, and mortality.

Results  Surgical site infection occurred in 131 of 685 patients (19.1%) assigned to receive 80% oxygen vs 141 of 701 (20.1%) assigned to receive 30% oxygen (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.72-1.22; P = .64). Atelectasis occurred in 54 of 685 patients (7.9%) assigned to receive 80% oxygen vs 50 of 701 (7.1%) assigned to receive 30% oxygen (OR, 1.11; 95% CI, 0.75-1.66; P = .60), pneumonia in 41 (6.0%) vs 44 (6.3%) (OR, 0.95; 95% CI, 0.61-1.48; P = .82), respiratory failure in 38 (5.5%) vs 31 (4.4%) (OR, 1.27; 95% CI, 0.78-2.07; P = .34), and mortality within 30 days in 30 (4.4%) vs 20 (2.9%) (OR, 1.56; 95% CI, 0.88-2.77; P = .13).

Conclusion  Administration of 80% oxygen compared with 30% oxygen did not result in a difference in risk of surgical site infection after abdominal surgery.

Trial Registration  clinicaltrials.gov Identifier: NCT00364741

Author Affiliations: Department of Anaesthesia, Centre of Head and Orthopaedics (Drs Meyhoff and Rasmussen), Copenhagen Trial Unit, Center for Clinical Intervention Research (Dr Wetterslev), and Departments of Anaesthesia (Dr Henneberg) and Gynaecology (Drs Høgdall and Lundvall), The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen; Department of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen (Drs Jorgensen and Simonsen); Department of Anaesthesia, Bispebjerg Hospital, University of Copenhagen, Copenhagen (Drs Svendsen, Mollerup, and Lunn); Departments of Anaesthesia (Dr Martinsen) and Surgery (Drs Pulawska, Bundgaard, and Bugge), Vejle Hospital, Vejle; Departments of Anaesthesia (Dr Hansen) and Surgery (Drs Riber, Gocht-Jensen, and Walker), Copenhagen University Hospital, Herlev; Departments of Anaesthesia (Drs Bendtsen and Johansson) and Surgery (Dr Skovgaard), Copenhagen University Hospital, Amager, Copenhagen; Department of Anaesthesia, Nykøbing Falster Hospital, Nykøbing Falster (Drs Heltø and Poukinski); Departments of Anaesthesia (Drs Korshin and Walli) and Surgery (Dr Bulut), Slagelse Hospital, Slagelse; Department of Anaesthesiology, Aarhus University Hospital, Aarhus (Drs Carlsson, Rodt, and Lundbech); Departments of Anaesthesiology (Dr Rask) and Surgery (Dr Buch), Odense Universitetshospital, Svendborg; Department of Surgery, Naestved Hospital, Naestved (Drs Perdawid and Reza); Departments of Anaesthesia (Dr K. V. Jensen) and Surgery (Dr Carlsen), Viborg Hospital, Viborg; and Department of Anaesthesia, Copenhagen University Hospital, Gentofte (Dr F. S. Jensen), Denmark.

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