COPDNCT03863821
The Application and Analysis of HHHFNC in Walking Test of Pulmonary Rehabilitation
A study testing HHHFNC in people with COPD and Pulmonary Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Pulmonary Disease, Rehabilitation
- What is being tested?
- HHHFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2019to 30 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD with performed pulmonary function test
Who cannot join
- Left-side heart failure
- COPD exacerbation within 3 month
- Diagnosed neuromuscular disease
- Unable to perform 6-MWT
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Effects of Heated Humidified High-Flow Nasal Cannula During Six-Minute Walk Test in Patient With COPD Undergoing Pulmonary Rehabilitation
The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.
Read the detailed description
Objectives： The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.
Background： Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has similar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. Six-minute walking test (6-MWT) is a standardized laboratory tests to evaluate the endurance capacity in adult patients. It helps clinician to modify the treatment plan. Cirio, et at. has been shown HHHFNC may improve the exercise performance in severe chronic obstructive pulmonary disease (COPD) patients with ventilatory limitation.
Study Design： This is a prospective clinical trial in a pulmonary rehabilitation out-patient department (2018.08.01-2019.07.31).。 Methods： Patents with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD acute-exacerbation (AE) within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. The data will be collected for and analyzed.
Effect： Investigators expect the exercise performance; cardiopulmonary function will be improve under HHHFNC support. We hope the application of HHHFNC in adult patient with pulmonary rehabilitation could enhance the quality of life.
Key words： chronic obstructive pulmonary disease; heated humidified high-flow nasal cannula; pulmonary rehabilitation, six-minute walking test.
- Conditions
- COPD, Pulmonary Disease, Rehabilitation
- Being tested
- HHHFNC
- Keywords
- chronic obstructive pulmonary disease, heated humidified high-flow nasal cannula, pulmonary rehabilitation, six-minute walking test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHHFNCDevice
HHHFNC setting:
- Flow rate: 40L/min
- FiO2: 0.4
HHHFNC will use immediately before 6MWT and remove at the end of 6MWT
| Study group | Role | What they receive |
|---|---|---|
| HHHFNC group | Experimental | Practice 6 MWT with HHHFNC Receives: Device: HHHFNC |
| non-HHHFNC group | No intervention | Practice 6 MWT without HHHFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
Meter
Measured: 6 minutes
Secondary outcomes (5)
Heart rate
beat per minute
Measured: 1 hour
Oxygen saturation (SpO2)
Measured: 1 hour
Transcutaneous carbon dioxide (PtcCO2)
mmHg
Measured: 1 hour
Cardiac output by non-invasive cardiometry
mL
Measured: 1 hour
Borg dyspnea scale
0-10 level (level 10 means worst)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start18 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD AE within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. Participants will received HHHNFC or non-HHHFNC support during the 6-MWT.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863821
- Sponsor's protocol ID
- PL-201808008-M
- Status last verified
- Nov 2019
- First submitted
- 4 Mar 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
PubMed 27578482Maltais F, Singh S, Donald AC, Crater G, Church A, Goh AH, Riley JH. Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014 Dec;8(6):169-81. doi: 10.1177/1753465814559209.
PubMed 25452426Man WD, Mustfa N, Nikoletou D, Kaul S, Hart N, Rafferty GF, Donaldson N, Polkey MI, Moxham J. Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD. Thorax. 2004 Jun;59(6):471-6. doi: 10.1136/thx.2003.019620.
PubMed 15170026Chao KY, Liu WL, Nassef Y, Tseng CW, Wang JS. Effects of high-flow nasal cannula with oxygen on self-paced exercise performance in COPD: A randomized cross-over trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28032. doi: 10.1097/MD.0000000000028032.
PubMed 34941043
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heated Humidified High-Flow Nasal Cannula During Six-Minute Walk Test in Patient With COPD Undergoing Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03863821
- Acronym / sponsor ID
- PL-201808008-M
- Conditions
- COPD, Pulmonary Disease, Rehabilitation
- Keywords
- chronic obstructive pulmonary disease, heated humidified high-flow nasal cannula, pulmonary rehabilitation, six-minute walking test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Mar 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.
The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.
Detailed description
Objectives： The aim of this study is to investigate the use heated humidified high-flow nasal cannula (HHHFNC) in pulmonary rehabilitation and analysis of cardiopulmonary parameters in adult patients.
Background： Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has similar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. Six-minute walking test (6-MWT) is a standardized laboratory tests to evaluate the endurance capacity in adult patients. It helps clinician to modify the treatment plan. Cirio, et at. has been shown HHHFNC may improve the exercise performance in severe chronic obstructive pulmonary disease (COPD) patients with ventilatory limitation.
Study Design： This is a prospective clinical trial in a pulmonary rehabilitation out-patient department (2018.08.01-2019.07.31).。 Methods： Patents with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD acute-exacerbation (AE) within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. The data will be collected for and analyzed.
Effect： Investigators expect the exercise performance; cardiopulmonary function will be improve under HHHFNC support. We hope the application of HHHFNC in adult patient with pulmonary rehabilitation could enhance the quality of life.
Key words： chronic obstructive pulmonary disease; heated humidified high-flow nasal cannula; pulmonary rehabilitation, six-minute walking test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with COPD who done pulmonary function test will enroll to this study. Left-side heart failure, COPD AE within 3 months, diagnosed neuromuscular disease, and unable to perform 6-MWT will be exclude. Participants will received HHHNFC or non-HHHFNC support during the 6-MWT.
| Arm | Type | Receives |
|---|---|---|
| HHHFNC group | Experimental | Device: HHHFNCPractice 6 MWT with HHHFNC |
| non-HHHFNC group | No intervention | –Practice 6 MWT without HHHFNC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD with performed pulmonary function test
Key exclusion criteria (4 listed)
- Left-side heart failure
- COPD exacerbation within 3 month
- Diagnosed neuromuscular disease
- Unable to perform 6-MWT
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 |
|---|---|---|
| HHHFNCHHHFNC setting: 1. Flow rate: 40L/min 2. FiO2: 0.4 HHHFNC will use immediately before 6MWT and remove at the end of 6MWT | Device | HHHFNC group |
Primary outcome
Walking distance
Time frame: 6 minutes
Meter
5 secondary outcomes
Heart rate
Time frame: 1 hour
Oxygen saturation (SpO2)
Time frame: 1 hour
Transcutaneous carbon dioxide (PtcCO2)
Time frame: 1 hour
Cardiac output by non-invasive cardiometry
Time frame: 1 hour
Borg dyspnea scale
Time frame: 1 hour
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 30 Dec 2019.
- Results publication: PubMed 27578482Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
- Results publication: PubMed 25452426Maltais F, Singh S, Donald AC, Crater G, Church A, Goh AH, Riley JH. Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials. Ther Adv Respir Dis. 2014 Dec;8(6):169-81. doi: 10.1177/1753465814559209.
- Results publication: PubMed 15170026Man WD, Mustfa N, Nikoletou D, Kaul S, Hart N, Rafferty GF, Donaldson N, Polkey MI, Moxham J. Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD. Thorax. 2004 Jun;59(6):471-6. doi: 10.1136/thx.2003.019620.
- Derived from this study: PubMed 34941043Chao KY, Liu WL, Nassef Y, Tseng CW, Wang JS. Effects of high-flow nasal cannula with oxygen on self-paced exercise performance in COPD: A randomized cross-over trial. Medicine (Baltimore). 2021 Dec 23;100(51):e28032. doi: 10.1097/MD.0000000000028032.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHHFNC in people with COPD and Pulmonary Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 30 Dec 2019. 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 Taiwan. 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?
Walking distance (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863821, which also lists 4 linked publications.
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 30 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.