Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
研究概览
简要总结
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.
The main questions this study aims to answer are:
- Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?
- Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?
Researchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.
Participants will:
- Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles
- Have their muscle strength checked during the study
- Complete a survey three months after ICU discharge to check on their recovery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to ER or ICU within the previous 48 hours
- •APACHE II score ≥ 13
- •Meets the criteria for sepsis or severe sepsis
排除标准
- •Anticipated transfer to an ICU not participating in this study
- •Myopathies (e.g. congenital)
- •Acquired myopathies with CK levels 5-times above the upper limit of normal
- •Unable to transfer from bed to chair at baseline
- •Comfort care
- •New onset deep vein thrombosis within the previous 6-months
- •Malignancy in lower limb
- •Technical obstacles - fracture, burns, amputation
- •Open wound or skin abrasion at the garment application site
- •Pregnancy
- •Pacemaker and implantable cardioverter-defibrillator
研究组 & 干预措施
Intervention Group
Participants will receive a daily 60-minute session of electrical muscle stimulation applied to the quadriceps for up to 7 days during ICU stay or until ICU discharge, alongside standard of care.
干预措施: Electrical Muscle Stimulation System (Device)
Control Group
Participants will receive standard of care only
结局指标
主要结局
Change in lower limb muscle strength assessed by MRC sum score from ICU admission to ICU discharge.
时间窗: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.
Lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Six muscle groups in lower limbs will be tested for a total best possible score of 30. A 1-point increase in MRC score per muscle group in the lower limbs is considered clinically significant.
Number of participants with unanticipated adverse device effects (UADE) related to MyokinE100 use from enrollment to hospital discharge.
时间窗: From Day 1 (enrollment) through the end of the subject's study participation at 3-months.
A single Unanticipated Adverse Device Effect (UADE) in any participant during the study is considered significant.
次要结局
- Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.(Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.)
- Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge.(Day 1 (day of enrollment) and daily in the ICU up to Day 14, and on hospital discharge day.)
- Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge.(Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.)
- Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge.(Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.)
- Change in functional exercise capacity assessed by 30-Second Sit-to-Stand Test (30 s STS) between ICU discharge to hospital discharge.(Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.)
- Change in Rectus Femoris muscle structure assessed by musculoskeletal ultrasound from ICU admission to hospital discharge.(From ICU admission to day 14.)
- Change in frailty status assessed by Clinical Frailty Scale (CFS) from ICU admission to 3-month post hospital discharge.(Enrollment to 3-month follow-up.)
- Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge.(Enrollment to 3-month follow-up.)
- Change in fatigue severity assessed by Visual Analog Scale for Fatigue (VAS-F) from ICU admission to hospital discharge.(From ICU admission up to Day 14 or upon ICU discharge whichever comes first.)
- Change in health-related quality of life assessed by the RAND 36-Item Health Survey (SF-36) from the time of hospital discharge to 3-month follow-up after hospital discharge.(Hospital discharge to 3-month follow-up after hospital discharge.)
- Change in employment status and work ability after hospital discharge.(From ICU discharge to 3-month follow up after hospital discharge.)
- Duration of mechanical ventilation.(From ICU admission to ICU discharge, an average of 7 days.)
- Number of ventilator-free days within 28 days after ICU admission.(From extubation to day 28.)
- Number of days in ICU, hospital ward, and total hospital stay from admission to discharge.(From hospital admission to hospital discharge, an average of 14 days.)
- Discharge location after hospital stay.(At the last day of hospitalization, average day 14.)
- Number of participants tolerating electrical muscle stimulation sessions during ICU stay.(From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.)
- Number of participants with electrical interference on ECG monitoring during the stimulation sessions in the ICU.(From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.)
- Number of participants achieving significant muscle contraction during electrical muscle stimulation sessions as assessed by Muscle Contraction Scale during the ICU stay.(From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.)