- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877121
Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- TheFirst Affiliated Hospital Of Guangzhou Medical Collage
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
Exclusion Criteria:
- Severe Cardiovascular disease
- Pneumonia
- Neuromuscular and chest wall deformity
- Respiratory arrest
- Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
- Change in mental status; uncooperative patient
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)
Time Frame: 20-30minutes
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20-30minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the The diaphragm electromyogram (EMGdi)(10-300uv )
Time Frame: 20-30minutes
|
20-30minutes
|
the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)
Time Frame: 20-30minutes
|
20-30minutes
|
The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease
Time Frame: 20-30minutes
|
20-30minutes
|
The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)
Time Frame: 20-30minutes
|
20-30minutes
|
The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)
Time Frame: 20-30minutes
|
20-30minutes
|
The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)
Time Frame: 20-30minutes
|
20-30minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- gird2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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