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临床试验/NCT04741724
NCT04741724已完成不适用

Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation

Chang Gung University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
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

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,

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Yen-Huey

Associate lecture

Chang Gung University

研究点 (2)

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