A Randomized Controlled Trial of a Hospital-Grade Weighted Blanket to Improve Sedation Quality During Ventilator Weaning in the Blake 7 MICU (MGH)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Sedation quality
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Weighted blanket
The intervention group will receive the hospital-grade weighted blanket, to add on to usual care.
干预措施: Weighted blanket (Device)
Standard hospital linens
The control group will receive standard hospital bedding, which is part of usual care.
干预措施: Standard hospital linens (Device)
结局指标
主要结局
Sedation quality
时间窗: Every 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.
次要结局
- 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.)
- Anxiety scores(Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.)
- ICU length of stay(From ICU admission until ICU discharge, assessed for up to one month.)
- Incidence of sustained elevated core temperature(Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.)
- Feasibility success(From study initiation until the last participant completes study participation, assessed for up to 1 year.)
- Incidence of new Grade 2 or higher pressure injury on the anterior body surface(Every 4 hours from initiation of ventilator weaning until extubation, assessed for up to two weeks.)
研究者
Jennifer Cahill
Nurse Scientist and Instructor in Psychology, Department of Psychiatry
Massachusetts General Hospital