Chronic Obstructive Pulmonary DiseaseNCT04840628
The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
A study testing Resistance of the respiratory system in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Resistance of the respiratory system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2020to 3 Jul 2021
- Phase
- Interventional
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease patients with respiratory failure
Who cannot join
- Heart failure
- cardiac dysrhythmia
- Loss of consciousness
Trial locations and contacts
1 site in 1 country.
China1 site
1State Key Laboratory of Respiratory Disease, National clinical research center for respiratory disease, Guangzhou Institute of respiratory health. 2The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 520120
About this study
Official title: The Relationship Between the Nreural Drive and Intrinsic Positive End-expiratory Pressure of the Chronic Obstructive Pulmonary Disease Patients With Respiratory Failure
To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive was recorded.
Read the detailed description
To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair esophageal electrode catheter All the signal recorded in the computer. The relation the nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would be analysed.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Resistance of the respiratory system
- Keywords
- neural respiratory drive, Intrinsic Positive End-expiratory Pressure, Chronic Obstructive Pulmonary Disease Patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance of the respiratory systemOther
increase the resistance of the respiratory system of the chronic obstructive pulmonary disease patients
| Study group | Role | What they receive |
|---|---|---|
| neural respiratory drive | Experimental | neural respiratory drive assessed by EMGdi recorded from a multipair esophageal electrode Receives: Other: Resistance of the respiratory system |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) obtained from the a multi-pair esophageal electrode catheter
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start20 Nov 2020
- Primary completion21 Jun 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the chronic obstructive pulmonary disease patients with respiratory failure
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840628
- Sponsor's protocol ID
- YLS2020(142)
- Status last verified
- Feb 2022
- First submitted
- 27 Nov 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will share our data by publishing the paper
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Nreural Drive and Intrinsic Positive End-expiratory Pressure of the Chronic Obstructive Pulmonary Disease Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT04840628
- Acronym / sponsor ID
- YLS2020(142)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- neural respiratory drive, Intrinsic Positive End-expiratory Pressure, Chronic Obstructive Pulmonary Disease Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- 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.
To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive was recorded.
Detailed description
To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair esophageal electrode catheter All the signal recorded in the computer. The relation the nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would be analysed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the chronic obstructive pulmonary disease patients with respiratory failure
| Arm | Type | Receives |
|---|---|---|
| neural respiratory drive | Experimental | Other: Resistance of the respiratory systemneural respiratory drive assessed by EMGdi recorded from a multipair esophageal electrode |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic obstructive pulmonary disease patients with respiratory failure
Key exclusion criteria (3 listed)
- Heart failure
- cardiac dysrhythmia
- Loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance of the respiratory systemincrease the resistance of the respiratory system of the chronic obstructive pulmonary disease patients | Other | neural respiratory drive |
Primary outcome
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure
Time frame: 1 hour
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) obtained from the a multi-pair esophageal electrode catheter
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 7 Feb 2022.
- Individual participant dataSharing planned: No. we will share our data by publishing the paper
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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?
A study testing Resistance of the respiratory system in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University 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 3 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 7 Feb 2022. 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?
neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure (time frame: 1 hour). 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 7 Feb 2022.