Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- breathing frequency
研究概览
简要总结
Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.
详细描述
Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.
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 years;
- •MV for > 6 h/day for > 21 days;
- •medical stability
排除标准
- •acute lung or systemic infection,
- •hemodynamic instability,
- •abdominal distention,
研究组 & 干预措施
transcutaneous electrical diaphragmatic stimulation (TEDS)
Subjects received daily TEDS (30min/day, 5days/week ) until the end of the weaning trial.
During TEDS, rectangular electrodes were placed on the parasternal region beside the xiphoid process; the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was performed by applying biphasic waves at a stimulation frequency of 30 Hz, pulse width of 400 μs. TEDS intensity was gradually increased until visible muscle contraction was observed. Each session lasts for 30 min day.
干预措施: TEDS (Device)
Control group
Subjects in the control group did not received TEDS program. Subjects in the control group received the same pre- and post-measurement as those in TEDS group. The control group received medical treatment as those in TEDS group. The pulmonary function was measured at the beginning and end of the intervention.
结局指标
主要结局
breathing frequency
时间窗: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of respiratory rate
Pimax
时间窗: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of max inspiratory pressure
Vt
时间窗: through study completion, an average of 2 weeks
The pulmonary function as assessed by the measurement of tidal volume
次要结局
- RCC days(through study completion, an average of 6 weeks)
- weaning rate(through study completion, an average of 6 weeks)
研究者
Chen Yen-Huey
Associate lecture
Chang Gung University