COPDNCT05097560
The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation
A study testing high flow nasal cannula and Venturi mask in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- high flow nasal cannula and Venturi mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2021to 31 Aug 2022
- 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
- hospitalized AECOPD patients
- be ambulatory by 48h after admission for AECOPD
- requires oxygen by screening exercise test
Who cannot join
- active coronary ischemia
- respiratory diseases other than COPD
- unstable vital signs
- unstable psychological status
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shiying
Guangzhou, Guangdong, 510120
Shiying Fang, MD, +8602083062882, fangshiying2019@126.com
Rongchang Chen, PhD, +8613902273260, chenrc@vip.163.com
About this study
Official title: The Effect of High Flow Nasal Cannula on Exercise Capacity Compared to Venturi Mask in COPD Patients Recovering From Acute Evacerbation
Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.
Read the detailed description
We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.
- Conditions
- COPD
- Being tested
- high flow nasal cannula, Venturi mask
- Keywords
- HFNC, PR
- 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.
high flow nasal cannulaDevice
HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.
Venturi maskDevice
VM is commonly used by COPD patients during exercise training.
| Study group | Role | What they receive |
|---|---|---|
| HFNC group | Experimental | * Set FiO2 28%
* Titrate the flow of HFNC at the highest tolerated value up to 60 L/min Receives: Device: high flow nasal cannula |
| VM group | Active comparator | - Keep FiO2 constant with VM and HFNC during the two trial Receives: Device: Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Endurance time for 10 minute steping test
Measured: 10 minute
Secondary outcomes (3)
Respiratory pattern
Respiratory pattern is calculated by the flow and time
Measured: 10 minute
Work of breathing
Work of breathing is calculated by the transdiaphragmatic pressure
Measured: 10 minute
Neural respiratory drive
Neural respiratory drive is calculated by diaphragm electromyogram
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start11 Aug 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiying Fang, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, PhD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097560
- Sponsor's protocol ID
- FAHGZ-20210811
- Status last verified
- Oct 2021
- First submitted
- 16 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Flow Nasal Cannula on Exercise Capacity Compared to Venturi Mask in COPD Patients Recovering From Acute Evacerbation
- ClinicalTrials.gov ID
- NCT05097560
- Acronym / sponsor ID
- FAHGZ-20210811
- Conditions
- COPD
- Keywords
- HFNC, PR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 28 Oct 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.
Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.
Detailed description
We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC group | Experimental | Device: high flow nasal cannula* Set FiO2 28% * Titrate the flow of HFNC at the highest tolerated value up to 60 L/min |
| VM group | Active comparator | Device: Venturi mask- Keep FiO2 constant with VM and HFNC during the two trial |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized AECOPD patients
- be ambulatory by 48h after admission for AECOPD
- requires oxygen by screening exercise test
Key exclusion criteria (4 listed)
- active coronary ischemia
- respiratory diseases other than COPD
- unstable vital signs
- unstable psychological status
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 |
|---|---|---|
| high flow nasal cannulaHFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing. | Device | HFNC group |
| Venturi maskVM is commonly used by COPD patients during exercise training. | Device | VM group |
Primary outcome
Endurance time
Time frame: 10 minute
Endurance time for 10 minute steping test
3 secondary outcomes
Respiratory pattern
Time frame: 10 minute
Work of breathing
Time frame: 10 minute
Neural respiratory drive
Time frame: 10 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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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, PhD study chair
The First Affiliated Hospital of 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 high flow nasal cannula and Venturi mask in people with COPD, 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 3 inclusion and 4 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 28 Oct 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 Shiying Fang, MD (+8602083062882, fangshiying2019@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (time frame: 10 minute). 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 28 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.