Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Transdiaphragmatic pressure (Pdi)
研究概览
简要总结
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.
详细描述
Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.
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
- None
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
- •aged ≥ 18 years
- •ventilated for at least 48 h with an expected stay of more than 7 days in the ICU
- •diaphragm thickening fraction (DTF)< 25%
排除标准
- •having a pacemaker
- •cutaneous lesion that could interfere with probes
- •previous diaphragmatic nerve paralysis
- •body mass index > 35 kg/m2
- •severe chronic obstructive pulmonary disease (FEV1/FVC<30%)
- •pregnancy or lactation
- •decision to withhold life-sustaining treatment
结局指标
主要结局
Transdiaphragmatic pressure (Pdi)
时间窗: Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days
Pdi=gastric pressure - esophageal pressure
次要结局
- Esophageal pressure-time product(Collected once a day after TEPNS for consecutive 5 days)
- Ventilation days(Collected at 28 days after enrollment)
- 28-day mortality(Collected at 28 days after enrollment)
- Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure(Collected once a day after TEPNS for consecutive 5 days)
- Length of ICU stay(Collected at 28 days after enrollment)
研究者
Wang Zongyu
Principal Investigator
Peking University Third Hospital