Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial.

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.

[1]  C. Carlsson,et al.  Can postoperative continuous positive airway pressure (CPAP) prevent pulmonary complications after abdominal surgery? , 2005, Intensive Care Medicine.

[2]  G. Foti,et al.  Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study , 2003, Intensive Care Medicine.

[3]  H H BENDIXEN,et al.  IMPAIRED OXYGENATION IN SURGICAL PATIENTS DURING GENERAL ANESTHESIA WITH CONTROLLED VENTILATION. A CONCEPT OF ATELECTASIS. , 1963, The New England journal of medicine.

[4]  U. Neumann,et al.  Postoperative tracheal extubation after orthotopic liver transplantation , 2001, Acta anaesthesiologica Scandinavica.

[5]  G. Hedenstierna,et al.  Atelectasis and lung function in the postoperative period , 1992, Acta anaesthesiologica Scandinavica.

[6]  S. Keenan,et al.  The effect of positive pressure airway support on mortality and the need for intubation in cardiogenic pulmonary edema: a systematic review. , 1998, Chest.

[7]  R. Califf,et al.  Monitoring and ensuring safety during clinical research. , 2001, JAMA.

[8]  H Fabel,et al.  [Noninvasive ventilation]. , 2000, Der Internist.

[9]  P. Schnyder,et al.  Prevention of Atelectasis Formation During Induction of General Anesthesia , 2003, Anesthesia and analgesia.

[10]  T. Evans International Consensus Conferences in Intensive Care Medicine: Non-invasive positive pressure ventilation in acute respiratory failure , 2001, Intensive Care Medicine.

[11]  J. Takala,et al.  Outcome and resource utilization in gastroenterological surgery , 2001, The British journal of surgery.

[12]  K. Lindner,et al.  Continuous positive airway pressure effect on functional residual capacity, vital capacity and its subdivisions. , 1987, Chest.

[13]  M. Antonelli,et al.  Noninvasive Positive Pressure Ventilation Using a Helmet in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Feasibility Study , 2004, Anesthesiology.

[14]  G. Drummond,et al.  Automatic CPAP Compared with Conventional Treatment for Episodic Hypoxemia and Sleep Disturbance after Major Abdominal Surgery , 2002, Anesthesiology.

[15]  C. Ackerley,et al.  Atelectasis causes vascular leak and lethal right ventricular failure in uninjured rat lungs. , 2003, American journal of respiratory and critical care medicine.

[16]  W. Henderson,et al.  Multifactorial Risk Index for Predicting Postoperative Respiratory Failure in Men After Major Noncardiac Surgery , 2000, Annals of surgery.

[17]  B. Baxter,et al.  Temporal patterns of postoperative complications. , 2003, Archives of surgery.

[18]  D. Hess,et al.  Noninvasive positive pressure ventilation for acute respiratory failure. , 1999, International anesthesiology clinics.

[19]  A D Bersten,et al.  Treatment of severe cardiogenic pulmonary edema with continuous positive airway pressure delivered by face mask. , 1991, The New England journal of medicine.

[20]  J. Daley,et al.  Risk factors for prolonged length of stay after major elective surgery. , 1999, Annals of surgery.

[21]  T Douglas Bradley,et al.  Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. , 2003, The New England journal of medicine.

[22]  P. Plant,et al.  Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial , 2000, The Lancet.

[23]  A. V. van Kaam,et al.  Reducing atelectasis attenuates bacterial growth and translocation in experimental pneumonia. , 2004, American journal of respiratory and critical care medicine.

[24]  S. Pocock Group sequential methods in the design and analysis of clinical trials , 1977 .

[25]  S. Epstein,et al.  Extubation failure: magnitude of the problem, impact on outcomes, and prevention , 2003, Current opinion in critical care.

[26]  K. K. Lan,et al.  Discrete sequential boundaries for clinical trials , 1983 .

[27]  E. L’her,et al.  Noninvasive continuous positive airway pressure ventilation using a new helmet interface: a case-control prospective pilot study , 2003, Intensive Care Medicine.

[28]  F Lemaire,et al.  Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. , 2000, JAMA.

[29]  Arthur S Slutsky,et al.  Data safety and monitoring boards. , 2004, The New England journal of medicine.

[30]  M. Antonelli,et al.  Noninvasive positive pressure ventilation delivered by helmet vs. standard face mask , 2003, Intensive Care Medicine.

[31]  W. O'Donohue National survey of the usage of lung expansion modalities for the prevention and treatment of postoperative atelectasis following abdominal and thoracic surgery. , 1985, Chest.

[32]  P B Imrey,et al.  Prevention of postoperative pulmonary complications with CPAP, incentive spirometry, and conservative therapy. , 1985, Chest.

[33]  M. Antonelli,et al.  Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study , 2001, Intensive Care Medicine.

[34]  J. Møller,et al.  Hypoxemia in the postanesthesia care unit: an observer study. , 1990, Anesthesiology.

[35]  I. L. Cohen Guidelines for the use of innovative therapies in sepsis. , 1993, Critical care medicine.

[36]  M. Lamy,et al.  The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. , 1994, American journal of respiratory and critical care medicine.

[37]  G. Hedenstierna Gas exchange during anaesthesia , 1990, British journal of anaesthesia.