PURPOSE: The objective was to compare the effectiveness of repositioning every 2 or 4 h for preventing pressure ulcer development in patients in intensive care unit under mechanical ventilation (MV). METHODS: This was a pragmatic, open-label randomized clinical trial in consecutive patients on an alternating pressure air mattress (APAM) requiring invasive MV for at least 24 h in a university hospital in Spain. Eligible participants were randomly assigned to groups for repositioning every 2 (n = 165) or 4 (n = 164) h. The primary outcome was the incidence of a pressure ulcer of at least grade II during ICU stay. RESULTS: A pressure ulcer of at least grade II developed in 10.3% (17/165) of patients turned every 2 h versus 13.4% (22/164) of those turned every 4 h (hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.46-1.71, P = 0.73). The composite end point of device-related adverse events was recorded in 47.9 versus 36.6% (HR 1.50, CI 95% 1.06-2.11, P = 0.02), unplanned extubation in 11.5 versus 6.7% (HR 1.77, 95% CI 0.84-3.75, P = 0. 13), and endotracheal tube obstruction in 36.4 versus 30.5%, respectively (HR 1.44, 95% CI 0.98-2.12, P = 0.065). The median (interquartile range) daily nursing workload for manual repositioning was 21 (14-27) versus 11 min/patient (8-15) (P < 0.001). CONCLUSIONS: A strategy aimed at increasing repositioning frequency (2 versus 4 h) in patients under MV and on an APAM did not reduce the incidence of pressure ulcers. However, it did increase device-related adverse events and daily nursing workload.
RCT Entities:
PURPOSE: The objective was to compare the effectiveness of repositioning every 2 or 4 h for preventing pressure ulcer development in patients in intensive care unit under mechanical ventilation (MV). METHODS: This was a pragmatic, open-label randomized clinical trial in consecutive patients on an alternating pressure air mattress (APAM) requiring invasive MV for at least 24 h in a university hospital in Spain. Eligible participants were randomly assigned to groups for repositioning every 2 (n = 165) or 4 (n = 164) h. The primary outcome was the incidence of a pressure ulcer of at least grade II during ICU stay. RESULTS: A pressure ulcer of at least grade II developed in 10.3% (17/165) of patients turned every 2 h versus 13.4% (22/164) of those turned every 4 h (hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.46-1.71, P = 0.73). The composite end point of device-related adverse events was recorded in 47.9 versus 36.6% (HR 1.50, CI 95% 1.06-2.11, P = 0.02), unplanned extubation in 11.5 versus 6.7% (HR 1.77, 95% CI 0.84-3.75, P = 0. 13), and endotracheal tube obstruction in 36.4 versus 30.5%, respectively (HR 1.44, 95% CI 0.98-2.12, P = 0.065). The median (interquartile range) daily nursing workload for manual repositioning was 21 (14-27) versus 11 min/patient (8-15) (P < 0.001). CONCLUSIONS: A strategy aimed at increasing repositioning frequency (2 versus 4 h) in patients under MV and on an APAM did not reduce the incidence of pressure ulcers. However, it did increase device-related adverse events and daily nursing workload.
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