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Enrolling By Invitation NCT07710469

Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

Conditions: Ventilated Patient in Intensive Care

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * Intubated and mechanically ventilated * Receiving sedation and/or analgesia * Documented clinical decision to initiate ventilator weaning * Patient or legally authorized representative (LAR)/healthcare proxy (HCP) able to provide informed consent Exclusion Criteria: * Conditions in which deep pressure / blanket application may compromise safety in the opinion of the treating clinical team * Braden Scale score ≤9 with evidence of significant skin compromise * Patients with pre-existing pressure injuries on posterior, weight-bearing body surfaces (e.g., sacrum, coccyx, heels) will be excluded * Recent major surgery or unstable fractures affecting the torso * Continuous prone positioning * Body mass index ≥35 kg/m² as a precautionary exclusion due to uncertainty regarding pressure distribution and respiratory mechanics during early feasibility testing * Concurrent enrollment in another interventional trial affecting sedation or ventilation * Anticipated withdrawal of life-sustaining therapy * Pregnant individuals in the 2nd or 3rd trimester

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07710469). StuddyBuddy aggregates publicly available trial information.