Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning (NCT07710469) | Clinical Trial Compass
By InvitationNot Applicable
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
United States64 participantsStarted 2026-08-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sedation quality
Timeframe: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.