High-flow Nasal CannulaNCT04481295
Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation
A study testing High-flow nasal cannula and Low SpO2 in people with High-flow Nasal Cannula and Exercise Capacity, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
Trial summary
The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure
- What is being tested?
- High-flow nasal cannula and Low SpO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 18 Jul 2020to Jul 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.
Who cannot join
- Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure.
- Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.
- Subjects with changes in LTOT prescription flow within the last month
- Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113
Yuichi Chihara, MD., PhD., 81-774-52-0065, yc.r03107@gmail.com
About this study
Official title: Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
Read the detailed description
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.
The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
- Conditions
- High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure, Optimal SpO2 Value
- Being tested
- High-flow nasal cannula, Low SpO2
- Keywords
- HFNC, 6MWD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulaOther
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
Low SpO2Other
Low SpO2
| Study group | Role | What they receive |
|---|---|---|
| High SpO2 group | Active comparator | In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min). Receives: Other: High-flow nasal cannula |
| Low SpO2 group | Active comparator | In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min). Receives: Other: Low SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Secondary outcomes (9)
Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start18 Jul 2020
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-flow Nasal CannulaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital Organization Minami Kyoto Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481295
- Sponsor's protocol ID
- 2019-24
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2020
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT04481295
- Acronym / sponsor ID
- 2019-24
- Conditions
- High-flow Nasal Cannula, Exercise Capacity, Chronic Respiratory Failure, Optimal SpO2 Value
- Keywords
- HFNC, 6MWD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Hospital Organization Minami Kyoto HospitalUniversity, hospital or other
- Study start
- 18 Jul 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Jul 2020 (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 purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
Detailed description
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.
The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High SpO2 group | Active comparator | Other: High-flow nasal cannulaIn this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min). |
| Low SpO2 group | Active comparator | Other: Low SpO2In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.
Key exclusion criteria (4 listed)
- Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure.
- Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.
- Subjects with changes in LTOT prescription flow within the last month
- Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal 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 cannulaThe nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions. | Other | High SpO2 group |
| Low SpO2Low SpO2 | Other | Low SpO2 group |
Primary outcome
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
9 secondary outcomes
Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Low SpO2 in people with High-flow Nasal Cannula and Exercise Capacity, run by National Hospital Organization Minami Kyoto Hospital at 1 site in Japan.
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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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 Japan. 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 Yuichi Chihara (81-774-52-0065, yc.r03107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation (time frame: four 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 28 Mar 2023.