Methods
Objective: To assess effi cacy of combining daily interruption
of sedation with physical and occupational
therapy on functional outcomes in patients receiving
mechanical ventilation in intensive care.
Design: Open label randomized clinical trial.
Setting: Study was conducted at two university hospitals
on patients receiving sedation and mechanical ventilation.
Subjects were those who received mechanical
ventilation for < 72 hrs, were functionally independent
prior to hospitalization, and were expected to continue
for at least 24 hrs after enrollment.
Subjects: 104 mechanically ventilated patients in the ICU.
Intervention: Patients were randomized to receive either
early exercise and mobilization (physical and occupational
therapy) during periods of daily interruption of
sedation (intervention; n=49) or daily interruption of
sedation with therapy as ordered by the primary care
team (control; n=55). Th erapists who undertook patient
assessments were blinded to treatment assignment.
Outcomes: Th e primary endpoint was the number of
patients returning to independent functional status at
hospital discharge defi ned as the ability to perform six
activities of daily living and the ability to walk
independently. Secondary endpoints included duration
of delirium and ventilator-free days during the fi rst 28
days of hospital stay.