Chronic Obstructive Pulmonary DiseaseNCT06390631
Effect of CPAP on Respiratory Load in COPD
A study testing Continuous Positive Airway Pressure in people with Chronic Obstructive Pulmonary Disease, run by State Key Laboratory of Respiratory Disease at 1 site in China.
Trial summary
Both intrinsic positive end expiratory pressure (PEEPi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with COPD. The application of extrinsic positive end expiratory pressure (PEEPe) supplied by CPAP has been claimed to reduce inspiratory load based on… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 9 Jul 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate after informed consent
- Males and females, any race and aged 40-80 years
- GOLD II-IV COPD (post-bronchodilator FEV1 < 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70)
Who cannot join
- Patients recovering from acute exacerbation less than 4 weeks.
- Patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CPAP on Respiratory Load and Lung Volume in Stable COPD
Both intrinsic positive end expiratory pressure (PEEPi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with COPD. The application of extrinsic positive end expiratory pressure (PEEPe) supplied by CPAP has been claimed to reduce inspiratory load based on change in esophageal pressure which could be significantly affected by change in lung volume and airflow. The investigator hypothesized that CPAP could increase respiratory load because it increases lung volume.
Read the detailed description
Objective: To assess the effect of CPAP on respiratory load and lung volume in stable COPD. Methods: Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O). Diaphragm EMG, esophageal pressure (Pes) and transdiaphragmatic pressure (Pdi) were recorded using balloon esophageal electrode catheter (Yinghui, Guangzhou, China). End inspiratory lung volume (EILV) was measured directly from a pneumotachograph combined with a three way valve under the different CPAP levels. Sensation of breathing difficulty was also assessed. In an additional study, the effect of airflow on pressure was investigated by a physical mode.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- COPD, CPAP, Diaphragm EMG
- 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.
Continuous Positive Airway PressureDevice
Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O).
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | CPAP treatment in COPD patients Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm EMG
assessment of the electrical activity of the diaphragm (EMG-di)
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Lung volume
measurement of end inspiratory lung volume (EILV)
Measured: 1-3 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)
Intrinsic positive end expiratory pressure (PEEPi)
PEEPi was calculated from the negative deflection in Pes from the onset of inspiratory effort to the point of zero flow during spontaneous breathing.
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Inspiratory pressure
assessment of esophageal pressure and transdiaphragmatic pressure by caculating tidal variations in Pes (∆Pes) and Pdi (∆Pdi) relatived to initiation of effort.
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Inspiratory work
the pressure-time product of the respiratory muscles (PTPes/min) and of the diaphragm (PTPdi/min) were calculated under the Pes and Pdi versus time curve and expressed per minute.
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Sensation of breathing effort
Using questionnaire to assess the sensation of breathing effort. Sensation of breath effort of CPAP use was divided into three types corresponding to -1, 0, 1 score respectively, 0 refers to the same sensation as the feeling of breathing at the atmosphere without CPAP; 1 refers to the more difficult sensation to breath at the CPAP condition than at the atmosphere.; -1 refers to the easier sensation to breath at the CPAP condition than at the atmosphere.
Measured: 5 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)
Secondary outcomes (6)
Respiratory rate (RR)
assessment of respiratory rate (RR)
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Tidal volume (Vt)
assessment of tidal volume
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Minute ventilation (VE)
assessment of minute ventilation
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Peak inspiratory flow rate
assessment of peak inspiratory flow rate
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Expiratory muscle EMG
assessment of the electrical activity of the internal oblique muscle (EMG-obl) and the rectus muscle (EMG-rec)
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Expiratory pressure
The change in Pga resulting from the contraction of the abdominal muscles during expiration was analyzed
Measured: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2024
- Primary completion1 Jul 2024
- Study completion9 Jul 2024
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CPAP treatment
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Ming Luo, State Key Laboratory of Respiratory Disease
- Investigators
- Yuanming Luo, PHD, Principal investigator, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390631
- Sponsor's protocol ID
- 2020 No.38
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared after the paper of this study publishing.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP on Respiratory Load and Lung Volume in Stable COPD
- ClinicalTrials.gov ID
- NCT06390631
- Acronym / sponsor ID
- 2020 No.38
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, CPAP, Diaphragm EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- State Key Laboratory of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 30 Apr 2024 (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.
Both intrinsic positive end expiratory pressure (PEEPi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with COPD. The application of extrinsic positive end expiratory pressure (PEEPe) supplied by CPAP has been claimed to reduce inspiratory load based on change in esophageal pressure which could be significantly affected by change in lung volume and airflow. The investigator hypothesized that CPAP could increase respiratory load because it increases lung volume.
Detailed description
Objective: To assess the effect of CPAP on respiratory load and lung volume in stable COPD. Methods: Patients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O). Diaphragm EMG, esophageal pressure (Pes) and transdiaphragmatic pressure (Pdi) were recorded using balloon esophageal electrode catheter (Yinghui, Guangzhou, China). End inspiratory lung volume (EILV) was measured directly from a pneumotachograph combined with a three way valve under the different CPAP levels. Sensation of breathing difficulty was also assessed. In an additional study, the effect of airflow on pressure was investigated by a physical mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CPAP treatment
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous Positive Airway PressureCPAP treatment in COPD patients |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate after informed consent
- Males and females, any race and aged 40-80 years
- GOLD II-IV COPD (post-bronchodilator FEV1 < 80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70)
Key exclusion criteria (2 listed)
- Patients recovering from acute exacerbation less than 4 weeks.
- Patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).
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 |
|---|---|---|
| Continuous Positive Airway PressurePatients with COPD were recruited to breath under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O). | Device | CPAP treatment |
Primary outcome
Diaphragm EMG
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
assessment of the electrical activity of the diaphragm (EMG-di)
Lung volume
Time frame: 1-3 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)
measurement of end inspiratory lung volume (EILV)
Intrinsic positive end expiratory pressure (PEEPi)
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
PEEPi was calculated from the negative deflection in Pes from the onset of inspiratory effort to the point of zero flow during spontaneous breathing.
Inspiratory pressure
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
assessment of esophageal pressure and transdiaphragmatic pressure by caculating tidal variations in Pes (∆Pes) and Pdi (∆Pdi) relatived to initiation of effort.
Inspiratory work
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
the pressure-time product of the respiratory muscles (PTPes/min) and of the diaphragm (PTPdi/min) were calculated under the Pes and Pdi versus time curve and expressed per minute.
Sensation of breathing effort
Time frame: 5 minutes after each CPAP level (0, 4, 6, 8 and 10 cm H2O)
Using questionnaire to assess the sensation of breathing effort. Sensation of breath effort of CPAP use was divided into three types corresponding to -1, 0, 1 score respectively, 0 refers to the same sensation as the feeling of breathing at the atmosphere without CPAP; 1 refers to the more difficult sensation to breath at the CPAP condition than at the atmosphere.; -1 refers to the easier sensation to breath at the CPAP condition than at the atmosphere.
6 secondary outcomes
Respiratory rate (RR)
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Tidal volume (Vt)
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Minute ventilation (VE)
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Peak inspiratory flow rate
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Expiratory muscle EMG
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
Expiratory pressure
Time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.
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 10 Jul 2024.
- Individual participant dataSharing planned: Yes. The data will be shared after the paper of this study publishing.
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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.
Yuanming Luo, PHD principal investigator
Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Chronic Obstructive Pulmonary Disease, run by State Key Laboratory of Respiratory Disease 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 3 inclusion and 2 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 10 Jul 2024. 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?
Diaphragm EMG (time frame: Around 5 minutes signals under the atmosphere pressure and different levels of CPAP (4, 6, 8 and 10 cm H2O) were recorded.). The study lists 6 primary outcomes in all. 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 10 Jul 2024.