Effects of Transcutaneous Electrical Diaphragmatic Stimulation on Respiratory Function in Patients With Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- rapid shallow breathing index
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
Patients on ventilation for ≥21 days were randomly assigned to TEDS and control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters (tidal volume, respiratory rate, and rapid shallow breathing index) 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
- Single (Participant)
盲法说明
Subjects were not informed of the results of allocation
入排标准
- 年龄范围
- 20 Years 至 —（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 (PaO2 ≥ 60 mmHg at 40% FiO2, absence of signs and symptoms of infection, and hemodynamic stability).
排除标准
- •Acute lung or systemic infection, hemodynamic instability, patients with pacemakers, abdominal distention, and pregnancy.
结局指标
主要结局
rapid shallow breathing index
时间窗: through study completion,an average of 4 weeks
respiratory rate/tidal volume
tidal volume
时间窗: through study completion,an average of 4 weeks
The tidal volume was measured by a spirometer
respiratory muscle strength (maximal inspiratory pressure)
时间窗: through study completion,an average of 4 weeks
pressure gauge
respiratory muscle strength (maximal expiratory pressure)
时间窗: through study completion,an average of 4 weeks
pressure gauge
次要结局
- weaning rate(through study completion,an average of 7 weeks)
- length of stay in respiratory care center(through study completion,an average of 7 weeks)