跳至主要内容
临床试验/NCT02877121
NCT02877121已完成不适用

Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease

Zhang Jianheng1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症

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
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)

研究概览

简要总结

The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease patients.

详细描述

In total, 50 patients with interstitial lung disease (ILD) are going to recruited.The patients are studied at the afternoon in a semirecumbent position. After the application of topical anaesthesia (2% xylocaine), the patient will be asked to swallow two balloon-tipped catheters and the multi-pair esophageal electrode catheter through the nose into the their right position.

At the first period, the stable signals of unassisted spontaneous breathing (about 10min) were chosen to be recorded. The Esophageal and gastric balloon-catheters are used to detect the intra-thoracic and abdominal pressure.The diaphragm electromyogram (EMGdi) will be recorded from a multipair esophageal electrode.The baseline data of the respiratory muscle activity will be detected by these catheters and electrode.p0.1 (the negative airway pressure generated during the first 100 ms of an occluded inspiration) will be also meassured.

After the first period, the nonvolitional tests on respiratory muscle function and strength (twitch mouth and transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (TwPmo and TwPdi) will be done.

After the second period,the patients will be ask to perform different maneuvers, including maximal inspiration against a closed valve ,maximal inspiration to total lung capacity (TLC),maximalexpiration at the total lung capacity (TLC) against a closed valve and maximal sniff from functional residual capacity(FRC).Each maneuver will repeated more than three times with an interval of 30 s or more. Inspiratory capacity(IC),global maximal inspiratory pressure (PImax), maximal sniff nasal pressure (SnPna) and maximalexpiratory pressure will be meassured with the balloon-catheters.The maximal value of the diaphragm electromyogram (EMGdi) will be recorded during these maneuvers.

研究设计

研究类型
Observational
观察模型
Cohort

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

  • Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease

排除标准

  • Severe Cardiovascular disease
  • Neuromuscular and chest wall deformity
  • Respiratory arrest
  • Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
  • Change in mental status; uncooperative patient

结局指标

主要结局

transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)

时间窗: 20-30minutes

次要结局

  • The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)(20-30minutes)
  • The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)(20-30minutes)
  • the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)(20-30minutes)
  • The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease(20-30minutes)
  • the The diaphragm electromyogram (EMGdi)(10-300uv )(20-30minutes)
  • The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)(20-30minutes)

研究者

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

Zhang Jianheng

Dr

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

Loading locations...

相似试验

Respiratory Muscle Function and Neural Respiratory... | 临床试验