Chronic Obstructive Pulmonary DiseaseNCT03237962
High Flow Nasal Cannula During Pulmonary Rehabilitation
A study testing High Flow Nasal Cannula and Nasal Cannula in people with Chronic Obstructive Pulmonary Disease, run by Chang Gung University at 2 sites in Taiwan.
Trial summary
The primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- 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
- 32 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2016to Aug 2018
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 55 years
- COPD patients with confirmed pulmonary function test results of FEV1<70%
- Regular follow-up at the pulmonary medicine clinic
- Stable condition without acute exacerbation
- No pulmonary rehabilitation training within a year
- None oxygen usage at home
- No smoking history or quit smoking
- Inform consent signed
Who cannot join
- Fever (Body Temperature >37.5°C)
- Acute infection symptoms
- Unstable cardiovascular status (Eg: Blood pressure >150/100 mmHg after medication usage, angina pectoris, or abnormal ECG)
- Activity restrictions due to orthopedic or neuromuscular disease
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Chang Gung Memorial Hospital
Taoyuan, 61363
About this study
Official title: Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation
The primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device.
The hypotheses was, with high flow nasal cannula usage while exercising, the physiological outcome measurements would be better than conventional oxygen therapy device. Also, the usage of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused by exercising.
Read the detailed description
Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle function of COPD patients. By exercise training, even patients with severe COPD can increase muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to improvements in exercise endurance, when exercising at a higher intensity, ventilation support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during exercise. Continuously exercising can also increase the motivation to exercise, reduce mood irritability and psychological burden caused by symptoms. By exercising, patient's health status can be both improved physically and mentally.
High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity provided by the HFNC reduces irritation caused by the high flow, which leads to the increase of user's tolerance with the device. With the half-closed system formed by a nasal prong, when the high flow enters the upper airway, continue positive airway pressure would be formed.
Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation program. Before starting the program, subjects were randomly assigned to high flow nasal cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group would receive an oxygen flow of 3 - 5L to maintain SpO2>90% and the HFNC group with high flow setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2>90%. When joining the pulmonary rehabilitation program, patients are required to exercise for approximately 45 minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will again be assessed and compared to the primary data that was collected from the beginning of the program.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High Flow Nasal Cannula, Nasal Cannula
- Keywords
- High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, COPD, Chronic Obstructive Pulmonary Disease
- 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
Also called HFNC
High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.
Nasal CannulaDevice
Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Patients are randomly assigned into High flow nasal cannula group for the exercise training Receives: Device: High Flow Nasal Cannula |
| Nasal Cannula | Experimental | Patients are randomly assigned into nasal cannula group for the exercise training. Receives: Device: Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output in L/min
Heart rate and stroke volume will be combined to report cardiac output in L/min
Measured: Changes from baseline to 6 weeks and 12 weeks
Secondary outcomes (7)
COPD Assessment Test (CAT)
Questionnaire designed to evaluate COPD patient's quality of life.
Measured: Changes from baseline to 6 weeks and 12 weeks
Modified Medical Research Council (mMRC) Dyspnea Scale
Scale to determine the breathlessness of COPD patients during their daily activity
Measured: Changes from baseline to 6 weeks and 12 weeks
The maximum inspiratory pressure in cmH2O
The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles
Measured: Changes from baseline to 6 weeks and 12 weeks
The maximum expiratory pressure in cmH2O
The maximum expiratory pressure in cmH2O
Measured: Changes from baseline to 6 weeks and 12 weeks
Tissue Saturation Index
Tissue Saturation Index measured by near-Infrared spectroscopy
Measured: Changes from baseline to 6 weeks and 12 weeks
Total Hemoglobin
Total Hemoglobin measured by near-Infrared spectroscopy
Measured: Changes from baseline to 6 weeks and 12 weeks
Borg Scale
Scale examining the level of dyspnea or the shortness of breath during exercise
Measured: Changes from baseline to 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study startAug 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Hui-Ling Lin, MSc, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237962
- Sponsor's protocol ID
- NMRPD1F0731
- Status last verified
- Feb 2019
- First submitted
- 16 Jul 2017
- Last updated
- 25 Feb 2019
- 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 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03237962
- Acronym / sponsor ID
- NMRPD1F0731
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, COPD, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 3 Aug 2017 (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 primary purpose of this study is to compare and assess the immediate and long-term effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen therapy device.
The hypotheses was, with high flow nasal cannula usage while exercising, the physiological outcome measurements would be better than conventional oxygen therapy device. Also, the usage of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused by exercising.
Detailed description
Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle function of COPD patients. By exercise training, even patients with severe COPD can increase muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to improvements in exercise endurance, when exercising at a higher intensity, ventilation support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during exercise. Continuously exercising can also increase the motivation to exercise, reduce mood irritability and psychological burden caused by symptoms. By exercising, patient's health status can be both improved physically and mentally.
High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity provided by the HFNC reduces irritation caused by the high flow, which leads to the increase of user's tolerance with the device. With the half-closed system formed by a nasal prong, when the high flow enters the upper airway, continue positive airway pressure would be formed.
Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation program. Before starting the program, subjects were randomly assigned to high flow nasal cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group would receive an oxygen flow of 3 - 5L to maintain SpO2>90% and the HFNC group with high flow setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2>90%. When joining the pulmonary rehabilitation program, patients are required to exercise for approximately 45 minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will again be assessed and compared to the primary data that was collected from the beginning of the program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Device: High Flow Nasal CannulaPatients are randomly assigned into High flow nasal cannula group for the exercise training |
| Nasal Cannula | Experimental | Device: Nasal CannulaPatients are randomly assigned into nasal cannula group for the exercise training. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 55 years
- COPD patients with confirmed pulmonary function test results of FEV1<70%
- Regular follow-up at the pulmonary medicine clinic
- Stable condition without acute exacerbation
- No pulmonary rehabilitation training within a year
Key exclusion criteria (4 listed)
- Fever (Body Temperature >37.5°C)
- Acute infection symptoms
- Unstable cardiovascular status (Eg: Blood pressure >150/100 mmHg after medication usage, angina pectoris, or abnormal ECG)
- Activity restrictions due to orthopedic or neuromuscular disease
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 CannulaAlso: HFNCHigh Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value. | Device | High Flow Nasal Cannula |
| Nasal CannulaNasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes. | Device | Nasal Cannula |
Primary outcome
Cardiac Output in L/min
Time frame: Changes from baseline to 6 weeks and 12 weeks
Heart rate and stroke volume will be combined to report cardiac output in L/min
7 secondary outcomes
COPD Assessment Test (CAT)
Time frame: Changes from baseline to 6 weeks and 12 weeks
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Changes from baseline to 6 weeks and 12 weeks
The maximum inspiratory pressure in cmH2O
Time frame: Changes from baseline to 6 weeks and 12 weeks
The maximum expiratory pressure in cmH2O
Time frame: Changes from baseline to 6 weeks and 12 weeks
Tissue Saturation Index
Time frame: Changes from baseline to 6 weeks and 12 weeks
Total Hemoglobin
Time frame: Changes from baseline to 6 weeks and 12 weeks
Borg Scale
Time frame: Changes from baseline to 6 weeks and 12 weeks
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 25 Feb 2019.
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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.
Hui-Ling Lin, MSc principal investigator
Chang Gung University
2 sites 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 Chronic Obstructive Pulmonary Disease, run by Chang Gung University at 2 sites 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 8 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cardiac Output in L/min (time frame: Changes from baseline to 6 weeks and 12 weeks). 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 25 Feb 2019.