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A Randomized Controlled Trial

Sean P. Keenan, MD,FRCPC,MSc; Caroline Powers, RRT; David G. McCormack, MD,FRCPC; Gary Block, MD,FRCPC

JAMA. 2002;287:3238-3244.

Context  Noninvasive positive-pressure ventilation (NPPV) has been demonstrated to be effective in preventing the need for endotracheal intubation in some patients who present with acute respiratory failure. It is also used for patients who develop acute respiratory distress after extubation, but there are no randomized controlled trials that address its effectiveness in this population.

Objective  To determine the effectiveness of NPPV compared with standard medical therapy in preventing the need for endotracheal reintubation in high-risk patients who develop respiratory distress during the first 48 hours after extubation.

Design  Randomized, controlled, unblinded study with concealed allocation conducted between August 1, 1996 and October 31, 1999.

Setting  An intensive care unit (ICU) in an academic, tertiary care hospital in Ontario.

Patients  Eighty-one patients with a history of cardiac or respiratory disease or who initially required ventilatory support for more than 2 days and who developed respiratory distress within 48 hours of extubation.

Interventions  Patients were randomly assigned to receive standard medical therapy alone (supplemental oxygen to maintain oxygen saturation by pulse oximetry 95%; n = 42) or NPPV by face mask plus standard medical therapy (n = 39).

Main Outcome Measures  Rates of reintubation, duration of mechanical ventilation, lengths of ICU and hospital stay, and hospital mortality.

Results  Comparing the NPPV group with the standard-therapy group, there was no difference in the rate of reintubation (72% vs 69%; relative risk, 1.04; 95% confidence interval, 0.78-1.38) or hospital mortality (31% for both groups; relative risk, 0.99; 95% confidence interval, 0.52-1.91). Similarly, no difference was found in duration of mechanical ventilation or length of ICU or hospital stay.

Conclusions  The addition of NPPV to standard medical therapy does not improve outcome in heterogeneous groups of patients who develop respiratory distress during the first 48 hours after extubation.

Author Affiliations: Department of Medicine, Royal Columbian Hospital, New Westminster, British Columbia, and Centre for Health Evaluation and Outcome Sciences, St Paul's Hospital and University of British Columbia, Vancouver (Dr Keenan); and Divisions of Critical Care (Ms Powers) and Respiratory Medicine (Dr McCormack), Department of Medicine, and Department of Anaesthesia (Dr Block), London Health Sciences Centre, University of Western Ontario, London, Ontario.

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