Clinical Application of the Effect of Respiratory Muscles Electrical Stimulation on Weaning in Patients With Difficult Weaning of the Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to Successful Weaning (days)
研究概览
简要总结
This trial evaluates whether transcutaneous diaphragmatic/phrenic nerve stimulation (TEDS), abdominal functional electrical stimulation (abFES), or their combination, accelerates and improves the quality of weaning from prolonged invasive mechanical ventilation (IMV), compared with standardized ICU care with sham stimulation.
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
- Double (Participant, 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
- •Invasive mechanical ventilation ≥21 days for PMV(at least 6 hours per day); expected ≥48 h Invasive mechanical ventilation.
- •Eligible for standardized weaning protocol and SBT assessment. Informed consent by participant or legally authorized representative.
排除标准
- •Non-screenable/unstable arrhythmia or hemodynamics; refractory hypoxemia/hypercapnia.
- •Pacemaker/ICD not shieldable; seizure disorder uncontrolled. Recent abdominal surgery or skin breakdown at electrode sites; BMI>35; pregnancy.
- •Prone positioning; continuous deep neuromuscular blockade; investigator deems unsuitable.
研究组 & 干预措施
TEDS Only
TEDS + Sham abFES
干预措施: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) (Device)
TEDS Only
TEDS + Sham abFES
干预措施: Sham abFES (Device)
Combined
TEDS + abFES
干预措施: TEDS (Transcutaneous Diaphragmatic/Phrenic Nerve Stimulation) (Device)
Control
Sham TEDS + Sham abFES + Standard Care
干预措施: Sham TEDS (Device)
Control
Sham TEDS + Sham abFES + Standard Care
干预措施: Sham abFES (Device)
abFES Only
abFES + Sham TEDS
干预措施: abFES (Functional Electrical Stimulation of Abdominal Muscles) (Device)
abFES Only
abFES + Sham TEDS
干预措施: Sham TEDS (Device)
Combined
TEDS + abFES
干预措施: abFES (Functional Electrical Stimulation of Abdominal Muscles) (Device)
结局指标
主要结局
Time to Successful Weaning (days)
时间窗: From randomization up to Day 28
Days from randomization to first day achieving ≥48 h free from invasive mechanical ventilation (IMV).
次要结局
- Ventilator-Free Days to Day 28 (VFDs-28)(Day 0-28 after randomization)
- Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)(Baseline to Day 28)
- Readmission(Readmission of 3 month/6 month/ 12 month)
- mortality(mortality of 3 month/6 month/ 12 month)
- Incidence of pulmonary infection(Incidence of pulmonary infection of 3 months/ 6 months/ 12 months)
- Change in Diaphragm Excursion (DE) Measured by M-mode Ultrasound from Baseline to Day 28 (cm)(Baseline (within 24 hours before randomization) and Day 28 after randomization)
- Change in Diaphragm Thickening Fraction (TFdi) from Baseline to Day 28 (%)(Baseline to Day 28)
- Change in Diaphragm Thickness (DT) Measured by B-mode Ultrasound from Baseline to Day 28 (mm)(Baseline to Day 28)
- Weaning Success From Invasive Mechanical Ventilation Within 28 Days (% of Participants)(Up to Day 28 after randomization)
- 28-Day In-hospital Cost From Randomization (CNY)(exactly 28 days)
- Change in PEF from Baseline to Day 28 (L/min)(Baseline to Day 28)
- Readmission(Readmission of 3 month/6 month/ 12 month)
- mortality(mortality of 3 month/6 month/ 12 month)
- Ventilator-Free Days to Day 28 (VFDs-28)(Day 0-28 after randomization)
研究者
Yi Li
Principal Investigator
Capital Medical University