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Clinical Trials/NCT02877121
NCT02877121
Completed
N/A

Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease

Zhang Jianheng1 site in 1 country50 target enrollmentJune 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
State Key Laboratory of Respiratory Disease
Sponsor
Zhang Jianheng
Enrollment
50
Locations
1
Primary Endpoint
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhang Jianheng
Responsible Party
Sponsor Investigator
Principal Investigator

Zhang Jianheng

Dr

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 20-30minutes

Secondary Outcomes

  • 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)

Study Sites (1)

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