COPNCT04054622
Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
An observational study of COP and Non-invasive Ventilation, run by Guangzhou Medical University at 1 site in China.
Trial summary
Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COP, Non-invasive Ventilation, Pulmonary Rehabilitation
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Dec 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD, according to the criteria set by the Global Initiative for Obstructive Lung Disease scientific committee, were asked to participate in the present study. Patients had to meet the following inclusion criteria: 1) Age 40-80, males and females; 2) Stage III and IV COPD; 3) Similar with non-invasive ventilation; 4) Willing to participate in the study; 5) Able to provide informed consent.
Who may be able to join
- Age 40-80, males and females;
- Stage III and IV COPD;
- Similar with non-invasive ventilation;
- Willing to participate in the study;
- Able to provide informed consent.
Who cannot join
- Presented with an acute exacerbation during previous 3 months;
- Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
- Intolerant with NIV
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong
Zhenfeng He, MD, 8602083062882, zfHe_2019@163.com
About this study
Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Non-invasive ventilation(NIV) is increasingly used during exercise training programmes in order to train patients at intensity levels higher than allowed by their clinical and pathophysiological conditions. Patient-ventilator asynchrony (PVA) describes the poor interaction between the patient and the ventilator and is the consequence of the respiratory muscle activity of the patient being opposed to the action of the ventilator.PVA have unfavourable clinical impace on gas exchange, dyspnoea perception, patient comfort and tolerance and reduced adherence to NIV. This study is going to detect whether the PVA will increase when COPD patients exercise with NIV supporingt
- Conditions
- COP, Non-invasive Ventilation, Pulmonary Rehabilitation
- Keywords
- patient-ventilator asynchrony
- Medical subject headings
- Patient-Ventilator Asynchrony
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony index
Asynchrony index is defined as the number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100
Measured: 5 hours
Secondary outcomes (4)
Severe Respiratory Insufficiency (SRI) Questionnaire
The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NIV. It includes 49 items on seven subscales.
Measured: 5 hours
COPD assessment test
The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Measured: 5 hours
Partial pressure of arterial blood carbon dioxide (PaCO2)
Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NIV for at least 1 hour.
Measured: 5 hours
6-minute walk test
The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Nov 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenfeng He, Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Study director, Guangzhou Institute of Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054622
- Sponsor's protocol ID
- GIRH-201922
- Status last verified
- Feb 2021
- First submitted
- 9 Aug 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-ventilator Asychrony During Non-invasive Ventilation When COPD Patients Doing Exercise
- ClinicalTrials.gov ID
- NCT04054622
- Acronym / sponsor ID
- GIRH-201922
- Conditions
- COP, Non-invasive Ventilation, Pulmonary Rehabilitation
- Keywords
- patient-ventilator asynchrony
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Aug 2019 (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.
Pulmonary rehabilitation programmes including aerobic exercise training have strong evidence of effectiveness in improving exercise capacity, dyspnoea and HRQL in patients with COPD. Therefore, current guidelines recommend pulmonary rehabilitation, including exercise training, in these patients. Non-invasive ventilation(NIV) is increasingly used during exercise training programmes in order to train patients at intensity levels higher than allowed by their clinical and pathophysiological conditions. Patient-ventilator asynchrony (PVA) describes the poor interaction between the patient and the ventilator and is the consequence of the respiratory muscle activity of the patient being opposed to the action of the ventilator.PVA have unfavourable clinical impace on gas exchange, dyspnoea perception, patient comfort and tolerance and reduced adherence to NIV. This study is going to detect whether the PVA will increase when COPD patients exercise with NIV supporingt
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD, according to the criteria set by the Global Initiative for Obstructive Lung Disease scientific committee, were asked to participate in the present study. Patients had to meet the following inclusion criteria: 1) Age 40-80, males and females; 2) Stage III and IV COPD; 3) Similar with non-invasive ventilation; 4) Willing to participate in the study; 5) Able to provide informed consent.
Key inclusion criteria (5 listed)
- Age 40-80, males and females;
- Stage III and IV COPD;
- Similar with non-invasive ventilation;
- Willing to participate in the study;
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- Presented with an acute exacerbation during previous 3 months;
- Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
- Intolerant with NIV
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
Asynchrony index
Time frame: 5 hours
Asynchrony index is defined as the number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100
4 secondary outcomes
Severe Respiratory Insufficiency (SRI) Questionnaire
Time frame: 5 hours
COPD assessment test
Time frame: 5 hours
Partial pressure of arterial blood carbon dioxide (PaCO2)
Time frame: 5 hours
6-minute walk test
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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 study director
Guangzhou Institute of Respiratory Health
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 COP and Non-invasive Ventilation, run by 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 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng He, MD (8602083062882, zfHe_2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony index (time frame: 5 hours). 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 23 Feb 2021.