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Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

NCT07710469 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-08-10

No results posted yet for this study

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

Conditions

  • Ventilated Patient in Intensive Care

Interventions

DEVICE

Weighted blanket

For participants in the weighted blanket group: * ICU nursing staff will place a hospital grade weighted blanket on the patient during ventilator weaning * The blanket will weigh approximately 10% of the patient's body weight, with a maximum weight of 20 pounds. * The blanket's weight may be adjusted as needed. The blanket is composed of individual squares weighing about 5 pounds each. These squares can be attached to form composite blankets with total weights of 10, 15, or 20 pounds * The blanket may be used in different configurations (full body, shoulder, or lap) based on the patient's tolerance and the nursing staff's clinical judgment * The blanket does not restrict movement, airway access, or routine medical care * Nursing staff may remove the blanket at any time for comfort, safety, procedures, or clinical reasons

DEVICE

Standard hospital linens

For participants in the standard hospital linens group: * Participants will receive standard hospital bedding during ventilator weaning. This is part of standard care for patients in the ICU * Bedding will be managed by ICU nursing staff according to routine clinical practice

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710469 on ClinicalTrials.gov