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临床试验/NCT02976324
NCT02976324已完成不适用

The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

Zhang Xiangyu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
cardiopulmonary function

研究概览

简要总结

This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

详细描述

Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of chronic cor pulmonale and admit to hospital

排除标准

  • pneumothorax or mediastinal emphysema
  • active tuberculosis
  • install a cardiac pacemaker
  • acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
  • pregnancies
  • end-stage patients (expected survival time less than 6 months)

研究组 & 干预措施

external diaphragmatic pacemaker group

Experimental

use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz

干预措施: external diaphragmatic pacemaker group (Device)

control group

No Intervention

No inervention, just receive conventional therapy

结局指标

主要结局

cardiopulmonary function

时间窗: 10 days

six miunte walk test

次要结局

  • MIP(10 DAYS)

研究者

发起方
Zhang Xiangyu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhang Xiangyu

Director of Intensive care medicine

Tongji University

研究点 (1)

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