Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

Conditions

• Ventilated Patient in Intensive Care

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Weighted blanket — DEVICE
  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
• Standard hospital linens — DEVICE
  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

Study Details

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

Key Dates

First listed

Jul 17, 2026

Start date

Aug 1, 2026

Status verified

Jul 2026

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Weighted blanket
  The intervention group will receive the hospital-grade weighted blanket, to add on to usual care.
• Sham Comparator: Standard hospital linens
  The control group will receive standard hospital bedding, which is part of usual care.

Primary Outcome Measure

Sedation quality [ Time Frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks. ]

Locations (1)

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