The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weaning Rate
研究概览
简要总结
The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are:
- High protein formula intake benefit in successful weaning from ventilator
- Core muscle rehabilitation benefit in successful weaning from ventilator
- neuromuscular electric stimulation benefit in successful weaning from ventilator
Participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES).
Researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
详细描述
The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator:
- High protein formula intake benefit in successful weaning from ventilator
- Core muscle rehabilitation benefit in successful weaning from ventilator
- neuromuscular electric stimulation benefit in successful weaning from ventilator
Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).
Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 20 year old
- •using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)
- •stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability)
- •maximal inspiratory pressure (MIP) < 30mmHg
- •under enteral nutrition (EN) via NG tube.
排除标准
- •Acute infection and sepsis (fever up to 38.5 degree)
- •Severe neuromuscular disease, or uncontrolled epilepsy
- •Bony fracture or DVT history
- •Wound over the abdomen
- •Congestive heart failure with EF < 40% or using pacemaker
- •BMI>35 kg/M2, or severe edema
- •Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded.
- •Under parenteral nutrition (PN)
- •Use pacemaker
结局指标
主要结局
Weaning Rate
时间窗: 3 months
weaning success defined as weaning from ventilator for 5 consecutive days
Weaning Rate
时间窗: 3 months
weaning success defined as weaning from ventilator for 5 consecutive days
次要结局
- In Hospital Mortality(3 months)
- Length of Mechanical Ventilator Usage(3 months)
- Length of ICU Stay(6 months)