State Key Laboratory of Respiratory DiseaseNCT02877121
Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease
An observational study of State Key Laboratory of Respiratory Disease, run by Zhang Jianheng at 1 site in China.
Trial summary
The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- State Key Laboratory of Respiratory Disease
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Interstitial Lung Disease patients
Who may be able to join
- Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
Who cannot join
- Severe Cardiovascular disease
- Pneumonia
- Neuromuscular and chest wall deformity
- Respiratory arrest
- Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
- Change in mental status; uncooperative patient
Trial locations and contacts
1 site in 1 country.
China1 site
TheFirst Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510000
About this study
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.
- Keywords
- interstitial lung disease, Respiratory Muscle Function, Neural Respiratory Drive
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)
Measured: 20-30minutes
Secondary outcomes (6)
the The diaphragm electromyogram (EMGdi)(10-300uv )
Measured: 20-30minutes
the negative airway pressure generated during the first 100 ms of an occluded (p0.1)(from -0.5 to -5cmH2O)
Measured: 20-30minutes
The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease
Measured: 20-30minutes
The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)
Measured: 20-30minutes
The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)
Measured: 20-30minutes
The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)
Measured: 20-30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for State Key Laboratory of Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Jianheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877121
- Sponsor's protocol ID
- gird2016
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02877121
- Acronym / sponsor ID
- gird2016
- Keywords
- interstitial lung disease, Respiratory Muscle Function, Neural Respiratory Drive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zhang JianhengUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interstitial Lung Disease patients
Key inclusion criteria (1 listed)
- Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
Key exclusion criteria (6 listed)
- Severe Cardiovascular disease
- Pneumonia
- Neuromuscular and chest wall deformity
- Respiratory arrest
- Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi)
Time frame: 20-30minutes
6 secondary outcomes
the The diaphragm electromyogram (EMGdi)(10-300uv )
Time frame: 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
The global maximal inspiratory pressure (PImax) of the Interstitial Lung Disease
Time frame: 20-30minutes
The maximal sniff nasal pressure (SnPna)of the Interstitial Lung Disease patients(5-100cmH2O)
Time frame: 20-30minutes
The maximalexpiratory pressure (MEP)of the Interstitial Lung Disease patients(5-100cmH2O)
Time frame: 20-30minutes
The twitch mouth and during bilateral magnetic phrenic nerve stimulation (TwPmo)(from -2 to-20cmH2O)
Time frame: 20-30minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of State Key Laboratory of Respiratory Disease, run by Zhang Jianheng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (5-20cmH2O)(TwPdi) (time frame: 20-30minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.