Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease

State Key Laboratory of Respiratory Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877121
• Other study ID #: gird2016
• Status: Completed
• Phase: N/A
• First received: August 10, 2016
• Last updated: December 16, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe Cardiovascular disease

2. Pneumonia

3. Neuromuscular and chest wall deformity

4. Respiratory arrest

5. Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)

6. Change in mental status; uncooperative patient

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Respiration Disorders
• Respiratory Tract Diseases
• State Key Laboratory of Respiratory Disease

Locations

Country	Name	City	State
China	TheFirst Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Jianheng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)		20-30minutes	No
Secondary	the The diaphragm electromyogram (EMGdi)(10-300uv )		20-30minutes	No
Secondary	the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)		20-30minutes	No
Secondary	The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease		20-30minutes	No
Secondary	The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)		20-30minutes	No
Secondary	The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)		20-30minutes	No
Secondary	The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)		20-30minutes	No