Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning

Official title

A Randomized Controlled Trial of a Hospital-Grade Weighted Blanket to Improve Sedation Quality During Ventilator Weaning in the Blake 7 MICU (MGH)

Overview

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

Detailed description

To help manage symptoms and discomfort while patients are being taken off of a breathing machine (ventilator weaning), patients are often treated with sedative medications to keep them calm or sleepy. While these medications are often necessary, they can sometimes lead to problems such as needing the breathing machine for longer, confusion (delirium), poor sleep, and longer stays in the ICU. Current ICU practice aims to use lighter levels of sedation when possible. As sedation is reduced, there is a need for safe, low-risk, non-medication approaches that help keep patients comfortable without affecting their alertness or breathing.

Previous studies suggest that weighted blankets may reduce anxiety and physiologic stress without negatively affecting vital signs. However, the standard design of commercially available weighted blankets can affect their safety and usability. These include materials and construction that are not ideal for hospital use, excessive heat retention, special washing requirements, limited ability to adjust blanket weight, and interference with medical lines, tubes, and equipment.

These observations, along with clinician feedback, informed the development of a hospital-grade weighted blanket designed specifically for ICU use. This weighted blanket allows the amount of weight to be adjusted (5-20 pounds) and can be applied in different ways (e. g., over the full body, on the shoulders, or on the lap) depending on patient needs. It is designed to work safely alongside standard hospital equipment and fits within routine ICU care.

This study will compare the use of this weighted blanket to standard hospital linens to understand whether this weighted blanket improves patient comfort. This study is a randomized controlled trial in which participants are randomly assigned to receive either (1) the weighted blanket or (2) standard hospital linens. The study will enroll 64 patients. Participants will remain in the study until removal of mechanical ventilation (extubation). All data collected are part of routine care, and patient care will not be altered by study participation.

The trial will take place at the Blake 7 Medical Intensive Care Unit at Massachusetts General Hospital.

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 blan
• 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

Primary outcome measures

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

Secondary outcome measures (10)

• Acceptability of study [Time frame: From initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Sedative and analgesic exposure [Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Time to extubation [Time frame: From initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Delirium incidence [Time frame: Daily from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Pain severity [Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Anxiety scores [Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• ICU length of stay [Time frame: From ICU admission until ICU discharge, assessed for up to one month.]
• Incidence of new Grade 2 or higher pressure injury [Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Incidence of sustained elevated core temperature [Time frame: Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.]
• Feasibility success [Time frame: From study initiation until the last participant completes study participation, assessed for up to 1 year.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Publications

• 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.
• 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
• 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
• 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, C PMID 30113379

Identifiers

NCT: NCT07710469 · 2026P000726

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗