Pulmonary Disease, Chronic ObstructiveNCT02655484
Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation
A study testing BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ） in people with Pulmonary Disease, Chronic Obstructive, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to May 2016
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications);
- physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted;
- dyspnea as a main symptom that limited daily activities.
Who cannot join
- subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray;
- examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
- a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
- a history of uncontrolled hypertension, or other respiratory diseases;
- oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen (FiO2) ≥ 0.5;
- patients with musculoskeletal or neurological disorders;
- or failure to comply with the research protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Evaluation of Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation
The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.
Read the detailed description
Non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2) rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）
- Keywords
- COPD, noninvasive ventilation, exercise, CO2 rebreathing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）Device
See details from arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Other | Oxygen was delivered to the face mask by a tube at a constant rate (5L/min) to keep the fingertip oxygen saturation at 90% or above. Ventilatory assistance was delivered using a BiPAP® Vision® ventilator (Respironics, Murrysville, Pennsylvania, USA) in BiPAP mode applied via a tightly fitting full face mask (Curative, Suzhou, China). A symptom-limited cycle exercise test was performed while assisted by non-invasive ventilation (NIV). All measurements were recorded at inspiratory pressure of 14 cmH2O, expiratory pressure of 4 cmH2O during rest and exercise. Breathing pattern, mean exhalation flow, mean plateau exhalation valve flow, the mean inspiratory fraction of CO2 (tidal FiCO2) reinsufflated from the circuit between the mask and the exhalation valve was measured for each breath. Receives: Device: BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ） |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean exhalation valve flow
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
Secondary outcomes (8)
mean exhalation flow
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
mean inspiratory fraction of CO2 for each tidal volume
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
fraction of end-tidal carbon dioxide partial pressure
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
inspiratory time
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
expiratory time
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
respiratory rate
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
inspiratory tidal volume
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
expiratory tidal volume
Measured: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RongChang Chen, Guangzhou Institute of Respiratory Disease
- Investigators
- Rongchang Chen, MD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655484
- Sponsor's protocol ID
- 2009CB522112
- Status last verified
- Jul 2016
- First submitted
- 6 Jan 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation
- ClinicalTrials.gov ID
- NCT02655484
- Acronym / sponsor ID
- 2009CB522112
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, noninvasive ventilation, exercise, CO2 rebreathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jan 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 was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.
Detailed description
Non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2) rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Other | Device: BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）Oxygen was delivered to the face mask by a tube at a constant rate (5L/min) to keep the fingertip oxygen saturation at 90% or above. Ventilatory assistance was delivered using a BiPAP® Vision® ventilator (Respironics, Murrysville, Pennsylvania, USA) in BiPAP mode applied via a tightly fitting full face mask (Curative, Suzhou, China). A symptom-limited cycle exercise test was performed while assisted by non-invasive ventilation (NIV). All measurements were recorded at inspiratory pressure of 14 cmH2O, expiratory pressure of 4 cmH2O during rest and exercise. Breathing pattern, mean exhalation flow, mean plateau exhalation valve flow, the mean inspiratory fraction of CO2 (tidal FiCO2) reinsufflated from the circuit between the mask and the exhalation valve was measured for each breath. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications);
- physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted;
- dyspnea as a main symptom that limited daily activities.
Key exclusion criteria (7 listed)
- subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray;
- examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
- a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
- a history of uncontrolled hypertension, or other respiratory diseases;
- oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen (FiO2) ≥ 0.5;
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 |
|---|---|---|
| BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ）See details from arm descriptions. | Device | COPD patients |
Primary outcome
mean exhalation valve flow
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
8 secondary outcomes
mean exhalation flow
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
mean inspiratory fraction of CO2 for each tidal volume
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
fraction of end-tidal carbon dioxide partial pressure
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
inspiratory time
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
expiratory time
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
respiratory rate
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
inspiratory tidal volume
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
expiratory tidal volume
Time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.
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 18 Jul 2016.
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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.
Rongchang Chen, MD principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP® Vision® ventilator（"Ventilator", "Philips Respironics™ BiPAP® Vision®" ） in people with Pulmonary Disease, Chronic Obstructive, run by Guangzhou Institute 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 7 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 18 Jul 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?
mean exhalation valve flow (time frame: Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.). 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 18 Jul 2016.