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CompletedNCT02877121Updated Dec 19, 2016

Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease

An observational study in State Key Laboratory of Respiratory Disease, sponsored by Zhang Jianheng. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-19.

Sponsored by Zhang Jianheng · Observational

Study type
Observational
Model
Cohort
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • State Key Laboratory of Respiratory Disease

Keywords

  • interstitial lung disease
  • Respiratory Muscle Function
  • Neural Respiratory Drive
03

In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's enrollment of 50 is below the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

This is the only study on the registry with Zhang Jianheng as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Interstitial Lung Disease patients

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 20-30minutes

Secondary outcomes

  1. the The diaphragm electromyogram (EMGdi)(10-300uv )

    Time frame: 20-30minutes

  2. the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)

    Time frame: 20-30minutes

  3. The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease

    Time frame: 20-30minutes

  4. The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)

    Time frame: 20-30minutes

  5. The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)

    Time frame: 20-30minutes

  6. The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)

    Time frame: 20-30minutes

07

Study locations

1 site
  • TheFirst Affiliated Hospital Of Guangzhou Medical Collage
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02877121
Lead sponsor
Zhang Jianheng
Responsible party
Zhang Jianheng (Dr, The First Affiliated Hospital of Guangzhou Medical University) — Sponsor-investigator
First posted
Aug 24, 2016
Start date
Jun 2016
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Dec 19, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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