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Weighted Blanket for Ventilator Weaning Comfort

This study is looking at whether a special hospital-grade weighted blanket can help patients feel more comfortable and calm while they are being taken off a breathing machine (ventilator weaning) in the Intensive Care Unit (ICU). Patients often feel anxious or agitated during this time, and weighted blankets might help without needing more sedatives. You could be eligible if you are 18 or older, on a ventilator, receiving sedation, and your doctors have decided to start weaning you off the ventilator. The study will compare patients using the weighted blanket to those using standard hospital linens. The main goal is to see if the weighted blanket improves how well patients are sedated, which will be checked every 4 hours until they are off the ventilator, for up to two weeks. The study plans to include 64 participants, but its current status is unclear.

Study design
This is an interventional study comparing a weighted blanket to standard hospital linens. It plans to enroll 64 participants.
What's involved
Participants will either receive a weighted blanket or standard hospital linens during ventilator weaning. Sedation quality will be assessed every 4 hours until extubation, for up to two weeks.
Compensation
Not stated in the trial record.
Follow-up
Sedation quality will be assessed for up to two weeks after the start of ventilator weaning.

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NCT07710469

Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
Massachusetts General Hospital
~64 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Weighted blanketStandard hospital linens

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sedation quality
Measured over Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.

Conditions

Ventilated Patient in Intensive Care

Explore related trials

Mechanical Ventilation

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Jennifer E. Cahill, PhD, RN · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sedation qualityEvery 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.

    Sedation and agitation will be measured using the Richmond Agitation-Sedation Scale (RASS). This scale ranges from +4 (combative) to -5 (unarousable), with 0 indicating an alert and calm state. Positive scores reflect agitation and negative scores reflect increasing levels of sedation. Sedation quality is defined as the proportion of time patients spend within a goal RASS score, between 0 to +1, during ventilator weaning. This range reflects intended light sedation during ventilator weaning to preserve alertness and respiratory drive.