Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to reach independence in performing functional activity
研究概览
简要总结
The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Duration of mechanical ventilation >14 days
- •Sufficiently awake
- •Able to speak and comprehend English
- •Willingness to participate
排除标准
- •Cardiopulmonary Instability
- •Acute-onset neuromuscular disease
- •Lower-extremity amputee or paresis
- •Open wound at electrode application points
- •Pitting edema grade ≥3
- •Presence of pacemaker, implanted defibrillator, or ventricular-assist device
- •inability to transfer from sitting to standing before critical illness
研究组 & 干预措施
Neuro-muscular electrical stimulation
Intervention:Neuromuscular electrical stimulation (NMES)
NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES
干预措施: Neuromuscular electrical Stimulation (NMES) (Device)
Sham stimulation
Intervention: sham stimulation
Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Time to reach independence in performing functional activity
时间窗: Hospital discharge, an expected average stay of 5 weeks
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
次要结局
- The percentage of patients who can perform functional activities independently(Hospital discharge, an expected average stay of 5 weeks)
研究者
Amal Jubran
Principal Investigator-Staff Physician
RML Specialty Hospital