Clinical trial NCT02877121: Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: State Key Laboratory of Respiratory Disease
Keywords: interstitial lung disease
Respiratory Muscle Function
Neural Respiratory Drive
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Interstitial Lung Disease patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)
timeFrame: 20-30minutes
Secondary outcomes:
measure: the The diaphragm electromyogram (EMGdi)(10-300uv )
timeFrame: 20-30minutes
measure: the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)
timeFrame: 20-30minutes
measure: The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease
timeFrame: 20-30minutes
measure: The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)
timeFrame: 20-30minutes
measure: The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)
timeFrame: 20-30minutes
measure: The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)
timeFrame: 20-30minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: TheFirst Affiliated Hospital Of Guangzhou Medical Collage
state: Guangdong
Study officials:
References: