COPDNCT04156724
Helmet Ventilation During Self-Paced Walking Test
A study testing Helmet vetilation in people with COPD, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Helmet vetilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2020to 1 Feb 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patents with COPD who confirm by pulmonary function test
Who cannot join
- COPD AE within 3 months
- 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: Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease
The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.
- Conditions
- COPD
- Being tested
- Helmet vetilation
- 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.
Helmet vetilationDevice
We will apply non-invasive positive pressure ventilation via a helmet as interface
| Study group | Role | What they receive |
|---|---|---|
| HV | Experimental | 6MWT with helmet ventilation Receives: Device: Helmet vetilation |
| Control | No intervention | 6MWT alone according to ATS guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
6WMD
Walking distance of six minute walking test
Measured: 2 days
Secondary outcomes (3)
Heart rate
Heart rate of six minute walking test
Measured: 2 days
Respiratory rate
Respiratory rate of six minute walking test
Measured: 2 days
modified Borg dyspnea scale
A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start14 Jul 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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
- Investigators
- Wen-Lun Liu, MD, Principal investigator, Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156724
- Sponsor's protocol ID
- C108032
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
PubMed 27179847Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.
PubMed 29595563Dreher M, Storre JH, Windisch W. Noninvasive ventilation during walking in patients with severe COPD: a randomised cross-over trial. Eur Respir J. 2007 May;29(5):930-6. doi: 10.1183/09031936.00075806. Epub 2007 Mar 1.
PubMed 17331969Chao KY, Liu WL, Nassef Y, Lai PZ, Wang JS. A pilot crossover trial assessing the exercise performance patients chronic obstructive pulmonary disease. Sci Rep. 2022 Mar 9;12(1):4158. doi: 10.1038/s41598-022-07698-z.
PubMed 35264615
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04156724
- Acronym / sponsor ID
- C108032
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 7 Nov 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 helmet ventilation (HV) in walking test and analysis of effect patients with COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HV | Experimental | Device: Helmet vetilation6MWT with helmet ventilation |
| Control | No intervention | –6MWT alone according to ATS guideline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patents with COPD who confirm by pulmonary function test
Key exclusion criteria (3 listed)
- COPD AE within 3 months
- 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 |
|---|---|---|
| Helmet vetilationWe will apply non-invasive positive pressure ventilation via a helmet as interface | Device | HV |
Primary outcome
6WMD
Time frame: 2 days
Walking distance of six minute walking test
3 secondary outcomes
Heart rate
Time frame: 2 days
Respiratory rate
Time frame: 2 days
modified Borg dyspnea scale
Time frame: 2 days
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 Sep 2021.
- Background: PubMed 27179847Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
- Background: PubMed 29595563Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.
- Background: PubMed 17331969Dreher M, Storre JH, Windisch W. Noninvasive ventilation during walking in patients with severe COPD: a randomised cross-over trial. Eur Respir J. 2007 May;29(5):930-6. doi: 10.1183/09031936.00075806. Epub 2007 Mar 1.
- Derived from this study: PubMed 35264615Chao KY, Liu WL, Nassef Y, Lai PZ, Wang JS. A pilot crossover trial assessing the exercise performance patients chronic obstructive pulmonary disease. Sci Rep. 2022 Mar 9;12(1):4158. doi: 10.1038/s41598-022-07698-z.
- 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.
Wen-Lun Liu, MD principal investigator
Department of Emergency and Critical Care Medicine, Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet vetilation in people with COPD, 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 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: finished, as of the sponsor's last update on 30 Sep 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 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?
6WMD (time frame: 2 days). 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 NCT04156724, 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 Sep 2021.