COPDNCT03883256
High Flow Nasal Cannula on Exercise Endurance in COPD
A study testing high flow nasal cannula and nasal cannula in people with COPD, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD
- What is being tested?
- high flow nasal cannula and nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2018to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with diagnosis of COPD
- OPD patients
- has no AE (within 1 month)
- not receiving any O2 therapy at home
- no smoking or quick
Who cannot join
- fever
- unstable hemodynamics at resting
- orthopadeic or neurologic problems that limited exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD
Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.
Read the detailed description
This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).
- Conditions
- COPD
- Being tested
- high flow nasal cannula, nasal cannula
- Keywords
- High flow nasal cannula oxygen, exercise performance, COPD
- 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
High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.
nasal cannulaDevice
Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula | Active comparator | Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device. Receives: Device: high flow nasal cannula |
| nasal cannula | Active comparator | Subjects perform a constant-load exercise test with nasal cannula oxygen device. Receives: Device: nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise time with high flow nasal cannula
the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device
Measured: end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device
exercise time with nasal cannula
the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device
Measured: end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device
Secondary outcomes (4)
Difference in cardiac output
Difference in end-exercise cardiac output in constant-load exercise test between HFNCO and NC
Measured: Baseline and 48 hours after baseline ]
Difference in stroke volume
Difference in end-exercise stroke volume in constant-load exercise test between HFNCO and NC
Measured: Baseline and 48 hours after baseline ]
Difference in muscle tissue oxygenation
Difference in end-exercise muscle tissue oxygenation in constant-load exercise test between HFNCO and NC
Measured: Baseline and 48 hours after baseline ]
Difference in cerebral tissue oxygenation
Difference in end-exercise cerebral tissue oxygenation in constant-load exercise test between HFNCO and NC
Measured: Baseline and 48 hours after baseline ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start25 May 2018
- 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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yen-Huey, Chang Gung University
- Investigators
- Yen-Huey Chen, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883256
- Sponsor's protocol ID
- 201800540A3
- Status last verified
- Feb 2021
- First submitted
- 10 Mar 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD
- ClinicalTrials.gov ID
- NCT03883256
- Acronym / sponsor ID
- 201800540A3
- Conditions
- COPD
- Keywords
- High flow nasal cannula oxygen, exercise performance, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 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.
Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.
Detailed description
This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula | Active comparator | Device: high flow nasal cannulaSubjects perform a constant-load exercise test with high flow nasal cannula oxygen device. |
| nasal cannula | Active comparator | Device: nasal cannulaSubjects perform a constant-load exercise test with nasal cannula oxygen device. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- with diagnosis of COPD
- OPD patients
- has no AE (within 1 month)
- not receiving any O2 therapy at home
- no smoking or quick
Key exclusion criteria (3 listed)
- fever
- unstable hemodynamics at resting
- orthopadeic or neurologic problems that limited exercise
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 cannulaHigh flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula. | Device | high flow nasal cannula |
| nasal cannulaNasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula. | Device | nasal cannula |
Primary outcome
exercise time with high flow nasal cannula
Time frame: end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device
the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device
exercise time with nasal cannula
Time frame: end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device
the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device
4 secondary outcomes
Difference in cardiac output
Time frame: Baseline and 48 hours after baseline ]
Difference in stroke volume
Time frame: Baseline and 48 hours after baseline ]
Difference in muscle tissue oxygenation
Time frame: Baseline and 48 hours after baseline ]
Difference in cerebral tissue oxygenation
Time frame: Baseline and 48 hours after baseline ]
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 4 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.
Yen-Huey Chen principal investigator
Chang Gung 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 nasal cannula in people with COPD, run by Chang Gung 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 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: finished, as of the sponsor's last update on 4 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 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?
exercise time with high flow nasal cannula (time frame: end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device). The study lists 2 primary outcomes in all. 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 4 Feb 2021.