Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score
研究概览
简要总结
The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.
详细描述
Survivors of critical illness frequently have significant, debilitating and persistent weakness after discharge from the intensive care unit (ICU). This weakness can persist for up to 4 years after ICU discharge. There are few interventions that have been successful in reducing or preventing weakness. Neuromuscular electrostimulation (NMES) therapy is beneficial in other populations of weak and functionally limited patients, such as those with chronic respiratory failure requiring mechanical ventilation, severe chronic obstructive pulmonary disease and end-stage congestive heart failure. We propose a randomized clinical trial to evaluate the efficacy of 60 minutes of NMES versus sham therapy, applied to the bilateral lower extremities, to reduce ICU-associated weakness in patients with acute respiratory failure. Our specific aims are to determine if NMES therapy will: 1) increase strength of the 3 treated lower extremity muscle groups (i.e., pretibial, triceps surae, and quadriceps), 2) improve important clinical outcomes (i.e., functional status, duration of mechanical ventilation, length of ICU and hospital stay, in-hospital mortality, and total hospital charges), 3) reduce critical illness myopathy as an etiology of weakness in clinically weak ICU patients. The investigators hypothesize that NMES therapy will reduce ICU-associated weakness, and improve clinical and functional outcomes. Additionally, the rates of critical illness myopathy as an etiology of weakness in clinically weak ICU patients will be lower in those receiving NMES versus sham therapy. Since there is no single test that is optimal for measuring muscle strength in the critically ill, the investigators will employ four non-invasive measures: manual muscle testing (MMT), hand held dynamometry (HHD), handgrip dynamometry (HGD), and maximal inspiratory pressure (MIP). With no existing therapeutic options available, our study explores the potential of NMES as a feasible intervention to reduce ICU-associated weakness.
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
- Single (Outcomes Assessor)
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
- •1 day of mechanical ventilation with an expectation of requiring ≥2 additional days of ICU stay in a Johns Hopkins Intensive Care Unit (ICU)
排除标准
- •Unable to understand or speak English due to language barrier or cognitive impairment prior to admission
- •Unable to independently transfer from bed to chair at baseline prior to hospital admission
- •Known primary systemic neuromuscular disease (e.g. Guillian-Barre) at ICU admission
- •Known intracranial process that is associated with localizing weakness (e.g. cerebral vascular accident) at ICU admission
- •Transferred from another ICU outside of the Johns Hopkins system after >4 consecutive days of mechanical ventilation
- •Moribund (i.e. >90% probability of patient mortality in the next 96 hours)
- •Anticipated transfer to another ICU for care (e.g. awaiting organ transplantation and transfer to surgical ICU)
- •Any pacemaker (e.g., cardiac, diaphragm) or implanted cardiac defibrillator
- •Pregnancy
- •Body mass index ≥35 kg/m2
- •Any limitation in life support other than a sole no-CPR order
- •Known or suspected malignancy in the legs
- •Unable to treat or evaluate both lower extremities (e.g., bilateral amputation, bilateral skin lesions)
- •ICU length of stay >7 days prior to enrollment
研究组 & 干预措施
NMES
60 minute daily NMES sessions every day for the duration of subject's ICU stay.
干预措施: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA) (Device)
Sham
60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.
干预措施: Sham (Device)
结局指标
主要结局
Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score
时间窗: At hospital discharge
Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups
次要结局
- Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength(ICU and hospital discharge)
- Overall Body Strength(ICU and hospital discharge)
- Hand Grip Strength(ICU and hospital discharge)
- Hospital Discharge Destination (e.g., Home, Rehab Facility)(Hospital discharge)
- Respiratory Muscle Strength(ICU and hospital discharge)
- Functional Status Measured Using Functional Status Score for the Intensive Care Unit(ICU and hospital discharge)
- Duration of Mechanical Ventilation(Until hospital discharge)
- ICU and Hospital Length of Stay(ICU and Hospital discharge)
- ICU and In-hospital Mortality(ICU discharge and Hospital discharge)
- Total Hospital Charges(Hospital discharge)
- Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)(At hospital discharge)
- Mean Change in Subject's Lower Extremity Muscle Strength Composite Score From Baseline(At ICU and Hospital discharge)
- ICU Delirium(During ICU stay - on days with study (NMES/Sham) session)
- Subgroup Analysis(ICU and hospital discharge and change over time)