Chronic Respiratory FailureNCT02804243
The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
A study testing nasal high flow therapy in people with Chronic Respiratory Failure and Nasal High Flow Therapy, 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 endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Respiratory Failure, Nasal High Flow Therapy, Rehabilitation
- What is being tested?
- nasal high flow therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2016to May 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 20 years and older
- 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, diabetes, neurological disease, and renal failure.
- Subject who are unable to undergo rehabilitation.
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Hospital Organization Minami Kyoto Hospital
Jōyō, Kyoto, 610-0113
About this study
The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with 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. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.
The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.
- Being tested
- nasal high flow therapy
- Keywords
- nasal high flow therapy, rehabilitation, exercise endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal high flow therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| nasal high flow therapy | Active comparator | In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks. Receives: Device: nasal high flow therapy |
| oxygen therapy | No intervention | In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walk distance (measured by six minutes walking test)
Measured: Four weeks
Secondary outcomes (8)
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Measured: Four weeks
Exercise tolerance test (exercise time et.)
Measured: Four weeks
Body composition measured by InBody (muscle mass et.)
Measured: Four weeks
Arterial blood gas
Measured: Four weeks
Inflammation (CRP et.)
Measured: Four weeks
Nutritional status (body mass index(kg/m2) et.)
Measured: Four weeks
Sympathetic activity (Catecholamine et.)
Measured: Four weeks
Dyspnea (Modified Borg scale)
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 posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
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
- NCT02804243
- Sponsor's protocol ID
- 27-10
- Status last verified
- Sep 2017
- First submitted
- 13 Jun 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.
PubMed 35644803
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT02804243
- Acronym / sponsor ID
- 27-10
- Keywords
- nasal high flow therapy, rehabilitation, exercise endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Hospital Organization Minami Kyoto HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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 endurance between oxygen therapy with rehabilitation and nasal high flow therapy with 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. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.
The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal high flow therapy | Active comparator | Device: nasal high flow therapyIn this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks. |
| oxygen therapy | No intervention | –In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks. |
Who may qualify
- Ages
- 20 years and older
- 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 (2 listed)
- Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
- Subject who are unable to undergo rehabilitation.
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 |
|---|---|---|
| nasal high flow therapyThe 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. | Device | nasal high flow therapy |
Primary outcome
Walk distance (measured by six minutes walking test)
Time frame: Four weeks
8 secondary outcomes
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Time frame: Four weeks
Exercise tolerance test (exercise time et.)
Time frame: Four weeks
Body composition measured by InBody (muscle mass et.)
Time frame: Four weeks
Arterial blood gas
Time frame: Four weeks
Inflammation (CRP et.)
Time frame: Four weeks
Nutritional status (body mass index(kg/m2) et.)
Time frame: Four weeks
Sympathetic activity (Catecholamine et.)
Time frame: Four weeks
Dyspnea (Modified Borg scale)
Time frame: Four 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 30 May 2018.
- Derived from this study: PubMed 35644803Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.
- Individual participant dataSharing planned: Yes
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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 nasal high flow therapy in people with Chronic Respiratory Failure and Nasal High Flow Therapy, 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 2 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 May 2018. 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?
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?
Walk distance (measured by six minutes walking test) (time frame: Four weeks). 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 NCT02804243, which also lists 1 linked publication.
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 May 2018.