Clinical Trial

Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

Enrolling by Invitation
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Summary
Patients in the ICU who are being taken off of a breathing machine (ventilator weaning) commonly experience anxiety, agitation, sleep disruption, and physiologic stress. Weighted blankets have been used to improve patient comfort; however, the design of standard weighted blankets can interfere with the ICU environment and are often not adaptable to individual patient needs. This study will evaluate a weighted blanket specifically designed for ICU use, with features that allow adjustable weight and flexible configuration (e. g., full body, shoulder, or lap). This study aims to determine whether the ICU-adapted weighted blanket: * Improves sedation quality, measured using the Richmond Agitation-Sedation Scale (RASS), which is already part of routine ICU care * Helps patients stay in a light, comfortable level of sedation during ventilator weaning * Is safe, feasible, and acceptable for use in the ICU environment Participants will be randomly assigned (like flipping a coin) to one of two groups: * Weighted blanket group, or * Standard linen group
Trial Details
NCT Number NCT07710469
Lead Sponsor Massachusetts General Hospital
Conditions Ventilated Patient in Intensive Care
Enrollment 64 participants
Start Date 2026-08-01
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10