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% versus 69%; relative risk 1.04; 95% confidence interval 0.78 to 1.38) or hospital mortality (31% for both groups; relative risk 0.99; 95% confidence interval 0.52 to 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.

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