Feasibility of implementing a multi-component intervention of environmental control in mechanically ventilated ICU patients to improve sleep: A pilot randomized controlled trial.

OBJECTIVES: To evaluate the feasibility of implementing a multi-component intervention in the ICU to promote sleep in critically ill patients. TRIAL DESIGN: A prospective, two-parallel-group, unblinded, pilot randomized controlled trial. METHODS: Adult patients ventilated for at least 48 h with no or superficial sedation in the past 24 h were recruited. They were randomized to receive a multi-component ICU environmental control intervention (dynamic light therapy, auditory masking, and rationalization of nighttime care) or standard care. A family member of each participant consented to the study. MAIN OUTCOME MEASURES: The primary outcomes were the feasibility of enrolling and retaining participants and the fidelity of the intervention. Secondary outcomes were sleep quantity (assessed by polysomnography and actigraphy) and sleep quality (assessed by Richards-Campbell Sleep Questionnaire), the prevalence of delirium at day three post-randomization, and neuropsychological impairment at six months post-ICU discharge. SETTING: An intensive care unit in a tertiary care teaching hospital in Santiago, Chile. RESULTS: 122 patients were screened; 17 were randomized, 9 to intervention and 8 to control. 78% (7) and 100% (8) stayed in ICU until day three. All 8 in the intervention group received the full intervention until ICU discharge. The enrollment rate was 94%. The 6-month follow-up rate was 35%, as some patients died. All participants who completed the study nights expressed very high satisfaction. CONCLUSIONS: This pilot study demonstrates the feasibility and acceptability of the intervention and informs methodological refinements for a future trial. IMPLICATIONS FOR CLINICAL PRACTICE: Implementing a multi-component environmental control intervention in intensive care units could improve short- and long-term outcomes in ventilated patients; however, further high-quality efficacy trials are required.