Chronic Obstructive Pulmonary Disease (COPD)NCT02285400
Effects of CPAP Level on Respiratory Mechanics and Central Drive in Patients With COPD
A study testing CPAP level in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Expiratory flow limitation (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- CPAP level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from Zhu jiang Hospital,Southern Medical University
- Patients aged 40-70 years old
- Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% and 30% ≤ FEV1%pred < 80%
- Patients in a clinically stable state
- Patients who signed informed consent.
Who cannot join
- Patients with signs of an airway infection
- Patients with an acute exacerbation during the previous 4 weeks
- Patients with giant bulla(≥3cm in diameter)
- Patients with recent upper abdominal surgery
- Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure
- Patients with poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: Effects of Continuous Positive Airway Pressure (CPAP) Level on Respiratory Mechanics and Central Drive in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Expiratory flow limitation (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle efforts and impaired central drive mechanical and ventilation coupling, which is an important mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe level on respiratory mechanics, especially on central drive mechanical and ventilation coupling, still need further investigations.
In the present study, about 40 patients with COPD will be recruited as research subjects. And the investigators aim to observe the changes in respiratory mechanics, central drive mechanics, central drive mechanical and ventilation coupling at different levels of CPAP. Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory mechanics and central drive during DPH, which may provide a reasonable basis for the clinical application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting method.
Read the detailed description
Patients with COPD are divided into two groups: moderate group and severe group, both of which are intervented by CPAP level. The static pressure volume curves of the lung and chest wall (Campbell diagram) were established with slow deep respiratory manoeuvre. Before using CPAP level, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, central drive mechanical and ventilation coupling. Then incremental CPAP level will be applied to investigate the effects of CPAP level on the above mentioned respiratory mechanics parameters.
- Being tested
- CPAP level
- Keywords
- COPD, CPAP, Central Drive
- 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.
CPAP levelProcedure or surgery
CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Moderate COPD patients | Experimental | Patients are connected to the noninvasive ventilator and incremental CPAP level is performed. Receives: Procedure: CPAP level |
| Severe COPD patients | Experimental | Patients are connected to the noninvasive ventilator and incremental CPAP level is performed. Receives: Procedure: CPAP level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic function
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
Measured: Change from baseline in diaphragm electromyogram at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Secondary outcomes (3)
Respiratory pressure
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Measured: Chang from baseline in respiratory pressure at 12 cmH2O CPAP level.(10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Respiratory volume
Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).
Measured: Chang from baseline in respiratory volume at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Degree of dyspnea
Difference in the degree of dyspnea can be measured by Borg index.
Measured: Chang from baseline in dyspnea at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285400
- Sponsor's protocol ID
- LY20140927
- Status last verified
- Jul 2015
- First submitted
- 11 Oct 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Positive Airway Pressure (CPAP) Level on Respiratory Mechanics and Central Drive in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02285400
- Acronym / sponsor ID
- LY20140927
- Keywords
- COPD, CPAP, Central Drive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Institute of Respiratory Disease
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Nov 2014 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Expiratory flow limitation (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle efforts and impaired central drive mechanical and ventilation coupling, which is an important mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe level on respiratory mechanics, especially on central drive mechanical and ventilation coupling, still need further investigations.
In the present study, about 40 patients with COPD will be recruited as research subjects. And the investigators aim to observe the changes in respiratory mechanics, central drive mechanics, central drive mechanical and ventilation coupling at different levels of CPAP. Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory mechanics and central drive during DPH, which may provide a reasonable basis for the clinical application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting method.
Detailed description
Patients with COPD are divided into two groups: moderate group and severe group, both of which are intervented by CPAP level. The static pressure volume curves of the lung and chest wall (Campbell diagram) were established with slow deep respiratory manoeuvre. Before using CPAP level, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, central drive mechanical and ventilation coupling. Then incremental CPAP level will be applied to investigate the effects of CPAP level on the above mentioned respiratory mechanics parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate COPD patients | Experimental | Procedure: CPAP levelPatients are connected to the noninvasive ventilator and incremental CPAP level is performed. |
| Severe COPD patients | Experimental | Procedure: CPAP levelPatients are connected to the noninvasive ventilator and incremental CPAP level is performed. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients from Zhu jiang Hospital,Southern Medical University
- Patients aged 40-70 years old
- Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% and 30% ≤ FEV1%pred < 80%
- Patients in a clinically stable state
- Patients who signed informed consent.
Key exclusion criteria (6 listed)
- Patients with signs of an airway infection
- Patients with an acute exacerbation during the previous 4 weeks
- Patients with giant bulla(≥3cm in diameter)
- Patients with recent upper abdominal surgery
- Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure
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 |
|---|---|---|
| CPAP levelCPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O. | Procedure or surgery | Moderate COPD patients, Severe COPD patients |
Primary outcome
Diaphragmatic function
Time frame: Change from baseline in diaphragm electromyogram at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
3 secondary outcomes
Respiratory pressure
Time frame: Chang from baseline in respiratory pressure at 12 cmH2O CPAP level.(10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Respiratory volume
Time frame: Chang from baseline in respiratory volume at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Degree of dyspnea
Time frame: Chang from baseline in dyspnea at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
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 31 Dec 2015.
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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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP level in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital 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 5 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 31 Dec 2015. 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?
Diaphragmatic function (time frame: Change from baseline in diaphragm electromyogram at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)). 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 31 Dec 2015.