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To compare a practice of protocol-directed sedation during mechanical ventilation implemented by nurses with traditional non-protocol-directed sedation administration.Randomized, controlled clinical trial.Medical intensive care unit (19 beds) in an urban teaching hospital.Patients requiring mechanical ventilation (n = 321).Patients were randomly assigned to receive either protocol-directed sedation (n = 162) or non-protocol-directed sedation (n = 159).The median duration of mechanical ventilation was 55.9 hrs (95% confidence interval, 41.0-90.0 hrs) for patients managed with protocol-directed sedation and 117.0 hrs (95% confidence interval, 96.0-155.6 hrs) for patients receiving non-protocol-directed sedation. Kaplan-Meier analysis demonstrated that patients in the protocol-directed sedation group had statistically shorter durations of mechanical ventilation than patients in the non-protocol-directed sedation group (chi-square = 7.00, p = .008, log rank test; chi-square = 8.54, p = .004, Wilcoxon's test; chi-square = 9.18, p = .003, −2 log test). Lengths of stay in the intensive care unit (5.7 ± 5.9 days vs. 7.5 ± 6.5 days; p = .013) and hospital (14.0 ± 17.3 days vs. 19.9 ± 24.2 days; p < .001) were also significantly shorter among patients in the protocol-directed sedation group. Among the 132 patients (41.1%) receiving continuous intravenous sedation, those in the protocol-directed sedation group (n = 66) had a significantly shorter duration of continuous intravenous sedation than those in the non-protocol-directed sedation group (n = 66) (3.5 ± 4.0 days vs. 5.6 ± 6.4 days; p = .003). Patients in the protocol-directed sedation group also had a significantly lower tracheostomy rate compared with patients in the non-protocol-directed sedation group (10 of 162 patients [6.2%] vs. 21 of 159 patients [13.2%], p = .038).The use of protocol-directed sedation can reduce the duration of mechanical ventilation, the intensive care unit and hospital lengths of stay, and the need for tracheostomy among critically ill patients with acute respiratory failure.