Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

NCT07710469 | Enrolling By Invitation FDA Device

• 1 other identifier: 2026P000726
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Weighted blankets; Mechanical ventilation; Nursing care; Nonpharmacologic interventions; Intensive care units; Sedation reduction

Outcome Measures

Primary Outcomes (1)

• Sedation quality

  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.

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

Secondary Outcomes (10)

• Acceptability of study

  From initiation of ventilator weaning until extubation, assessed for up to two weeks.

• Sedative and analgesic exposure

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

• Time to extubation

  From initiation of ventilator weaning until extubation, assessed for up to two weeks.

• Delirium incidence

  Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.

• Pain severity

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

Study Arms (2)

Weighted blanket

EXPERIMENTAL

The intervention group will receive the hospital-grade weighted blanket, to add on to usual care.

Device: Weighted blanket

Standard hospital linens

SHAM COMPARATOR

The control group will receive standard hospital bedding, which is part of usual care.

Device: Standard hospital linens

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

Weighted blanket

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

Standard hospital linens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concurrent enrollment in another interventional trial affecting sedation or ventilation
• Anticipated withdrawal of life-sustaining therapy
• Pregnant individuals in the 2nd or 3rd trimester

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Mullen B, Champagne T, Krishnamurty S, Dickson D, Gao RX. Exploring the safety and therapeutic effects of deep pressure stimulation using a weighted blanket. Am J Occup Ther. 2008;62(1):65-72.

  BACKGROUND

• Eron K, Kohnert L, Watters A, Logan C, Weisner-Rose M, Mehler PS. Weighted Blanket Use: A Systematic Review. Am J Occup Ther. 2020 Mar/Apr;74(2):7402205010p1-7402205010p14. doi: 10.5014/ajot.2020.037358.

  PMID: 32204779 BACKGROUND

• Olsen HT, Nedergaard HK, Strom T, Oxlund J, Wian KA, Ytrebo LM, Kroken BA, Chew M, Korkmaz S, Lauridsen JT, Toft P. Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients. N Engl J Med. 2020 Mar 19;382(12):1103-1111. doi: 10.1056/NEJMoa1906759. Epub 2020 Feb 16.

  PMID: 32068366 BACKGROUND

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 BACKGROUND

Study Officials

• Jennifer E. Cahill, PhD, RN

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist and Instructor in Psychology, Department of Psychiatry

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)