Chronic Obstructive Pulmonary DiseaseAIRVO-PHYSIONCT04014868
During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease
A study testing Nasal high-flow in people with Chronic Obstructive Pulmonary Disease, run by ADIR Association at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nasal high-flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2019to 10 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18years and < 80years;
- Chronic obstructive pulmonary disease Gold III-IV;
- Stable (no exacerbation) in the past 4 weeks;
- Referred for pulmonary rehabilitation (no cardiac, neurological, orthopedic, neuromuscular, psychological or psychiatric contra indication).
- Non-inclusion Criteria:
- Acute exacerbation of chronic obstructive pulmonary disease between the incremental cardiopulmonary exercise testing and inclusion;
Show all 11Show fewer
- Tracheostomy;
- Nasal high flow intolerance;
- Pregnancy or likely to be;
- Unable to consent;
- Patients under guardianship.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.
Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.
Read more
More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.
Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.
Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.
Read the detailed description
Experimental design:
Patients referred for pulmonary rehabilitation will be approached to participate in this study. Eligible patients who agree to participate in the study and sign informed consent will perform two constant workload exercise testing the same day with either nasal high-flow or sham nasal high-flow (separated by a 1 hour rest-period) in a randomized order.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nasal high-flow, Sham nasal high-flow
- Keywords
- Chronic obstructive pulmonary disease, Exercise, Nasal high flow, Muscle
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high-flowDevice
See arm description.
Sham nasal high-flowOther
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Nasal high-flow | Experimental | Patients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with active nasal high-flow :
Flow : 30 L/min; Temperature : 34°C;
The device will be out of sight of the patient. The device allow for oxygen supplementation (fitting on the back of the device). Usual oxygen prescription (if any) will be adjusted to reach a transcutaneous oxygen saturation superior to 90%. A second fitting will be placed just before the nasal canula to allow for oxygen supplementation during the sham nasal high-flow (device turned OFF) test.
Due to the cross-over design of the study, all patients will perform both interventions. Receives: Device: Nasal high-flow |
| Sham nasal high-flow | Sham comparator | Patients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with a sham nasal high-flow :
The procedure will be exactly the same but the device (out of sight of the patient) will be turned OFF. Oxygen supplementation will be possible through the fitting placed just before the nasal canula.
Due to the cross-over design of the study, all patients will perform both interventions. Receives: Other: Sham nasal high-flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transdiaphragmatic pressure-time product using a single-use catheter with two balloons to measure gastric and esophageal pressures.
Transdiaphragmatic pressure is calculated as gastric pressure minus oesophageal pressure. The outcome will be continuously recorded during the two constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Secondary outcomes (8)
Ventilatory drive using diaphragmatic electromyogram through the same single-use catheter used for transdiaphragmatic pressure (which is provided with 6 pairs of electrodes).
Diaphragmatic electromyography will be recorded with 6 pairs of electrodes and will be used as a surrogate for ventilatory drive. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Ventilatory efficiency using indirect calorimetry
Ventilatory efficiency will be assessed as the ratio between exercise ventilation to carbon dioxide production. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Dynamic hyperinflation using the fall in during-exercise inspiratory capacity
Maximal inspiratory maneuver will be performed every minute during the two constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Transcutaneous arterial carbon dioxide partial pressure using capnography.
The outcome will be measured at the earlobe. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Dyspnea during the constant workload exercise testing using modified Borg scale (0-10).
Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness). The dyspnea will be assessed every 30sec during the constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Vastus lateralis muscle peripheral perfusion during exercise using near infrared spectroscopy.
The outcome will be assessed every minute. Peripheral muscle perfusion will be assessed using the linear increase in total haemoglobin and myoglobin during a venous occlusion (20 seconds) and used as a surrogate for local blood perfusion. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Vastus lateralis muscular peripheral oxygen extraction during exercise using near infrared spectroscopy.
The outcome will be assessed continuously. Vastus lateralis muscle oxygen extraction will be assessed using deoxyhaemoglobin and deoxymyoglobin as a surrogate for peripheral oxygen extraction. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
Measured: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Endurance exercise capacity in seconds.
Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.
Measured: The outcome will be measured after every test. Data will be continuously collected during the tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start22 Nov 2019
- Primary completion1 Oct 2021
- Study completion10 Oct 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind randomized cross-over study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Cuvelier, MD, PhD, Prof, Principal investigator, Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, FranceJean-François Muir, MD, Prof, Study chair, ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, FranceMaxime Patout, MD, Msc, Study chair, Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, FranceTristan Bonnevie, Msc, Study chair, UADIR Association, Rouen University Hospital, Rouen, France ; niversity, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, FranceFrancis-Edouard Gravier, Msc, Study chair, ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014868
- Sponsor's protocol ID
- AIRVO-PHYSIO
- Acronym
- AIRVO-PHYSIO
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2019
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- During-exercise Physiological Effects of Nasal High-flow in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04014868
- Acronym / sponsor ID
- AIRVO-PHYSIO / AIRVO-PHYSIO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Exercise, Nasal high flow, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 10 Jul 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.
Chronic obstructive pulmonary disease is a major cause of disability and mortality worldwide. This disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation teaches chronic obstructive pulmonary disease patients to cope effectively with the systemic effects of the disease and improves exercise capacity, dyspnea and quality of life in patients with chronic obstructive pulmonary disease. However, the best training modality remains unknown. Physiological studies highlight the benefit of high intensity endurance training. However, many patients do not tolerate such a training due to ventilatory limitation and dyspnea. Therefore, a strategy to reduce dyspnea would allow a greater physiological muscle solicitation and improvement. Thus, many studies focus on means to increase exercise tolerance in patients with chronic obstructive pulmonary disease.
Nasal high flow delivers heated and humidified high flow air (up to 60 L/min) through nasal cannula providing physiological benefits such as positive airway pressure and carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.
More recently, nasal-high flow has been shown to improve endurance exercise capacity in patients with chronic obstructive pulmonary disease. However, the underlying physiological mechanisms have not been yet elucidated but may help to optimise the utilization of the device.
Therefore, the primary objective of this study is to assess the respiratory physiological effects nasal high-flow during-exercise in stable patients with chronic obstructive pulmonary disease.
Secondary objectives are to assess the effects nasal high-flow during-exercise on endurance capacity, respiratory drive, dynamic hyperinflation, cardiorespiratory pattern and muscular metabolism.
Detailed description
Experimental design:
Patients referred for pulmonary rehabilitation will be approached to participate in this study. Eligible patients who agree to participate in the study and sign informed consent will perform two constant workload exercise testing the same day with either nasal high-flow or sham nasal high-flow (separated by a 1 hour rest-period) in a randomized order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomized cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Nasal high-flow | Experimental | Device: Nasal high-flowPatients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with active nasal high-flow : Flow : 30 L/min; Temperature : 34°C; The device will be out of sight of the patient. The device allow for oxygen supplementation (fitting on the back of the device). Usual oxygen prescription (if any) will be adjusted to reach a transcutaneous oxygen saturation superior to 90%. A second fitting will be placed just before the nasal canula to allow for oxygen supplementation during the sham nasal high-flow (device turned OFF) test. Due to the cross-over design of the study, all patients will perform both interventions. |
| Sham nasal high-flow | Sham comparator | Other: Sham nasal high-flowPatients will perform a constant workload exercise testing (75% of the maximal workload achieved during a previously performed incremental cardiopulmonary exercise testing) with a sham nasal high-flow : The procedure will be exactly the same but the device (out of sight of the patient) will be turned OFF. Oxygen supplementation will be possible through the fitting placed just before the nasal canula. Due to the cross-over design of the study, all patients will perform both interventions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18years and < 80years;
- Chronic obstructive pulmonary disease Gold III-IV;
- Stable (no exacerbation) in the past 4 weeks;
- Referred for pulmonary rehabilitation (no cardiac, neurological, orthopedic, neuromuscular, psychological or psychiatric contra indication).
- Acute exacerbation of chronic obstructive pulmonary disease between the incremental cardiopulmonary exercise testing and inclusion;
Key exclusion criteria (0 listed)
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-flowSee arm description. | Device | Nasal high-flow |
| Sham nasal high-flowSee arm description. | Other | Sham nasal high-flow |
Primary outcome
Transdiaphragmatic pressure-time product using a single-use catheter with two balloons to measure gastric and esophageal pressures.
Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Transdiaphragmatic pressure is calculated as gastric pressure minus oesophageal pressure. The outcome will be continuously recorded during the two constant workload exercise testing. Results will be shown at time limit and iso time (defined as time limit of the shortest test).
8 secondary outcomes
Ventilatory drive using diaphragmatic electromyogram through the same single-use catheter used for transdiaphragmatic pressure (which is provided with 6 pairs of electrodes).
Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Ventilatory efficiency using indirect calorimetry
Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Dynamic hyperinflation using the fall in during-exercise inspiratory capacity
Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Transcutaneous arterial carbon dioxide partial pressure using capnography.
Time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.
Dyspnea during the constant workload exercise testing using modified Borg scale (0-10).
Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Vastus lateralis muscle peripheral perfusion during exercise using near infrared spectroscopy.
Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Vastus lateralis muscular peripheral oxygen extraction during exercise using near infrared spectroscopy.
Time frame: The outcome will be recorded during the two tests. The 2 tests will be performed the same day for a total time frame of 3hours.
Endurance exercise capacity in seconds.
Time frame: The outcome will be measured after every test. Data will be continuously collected during the tests. The 2 tests will be performed the same day for a total time frame of 3hours.
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 17 Mar 2022.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Antoine Cuvelier, MD, PhD, Prof principal investigator
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
Jean-François Muir, MD, Prof study chair
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
Maxime Patout, MD, Msc study chair
Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
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 in people with Chronic Obstructive Pulmonary Disease, run by ADIR Association at 1 site in France.
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 11 inclusion and 0 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 17 Mar 2022. 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 France. 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. Some participants in this study may receive a placebo. 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?
Transdiaphragmatic pressure-time product using a single-use catheter with two balloons to measure gastric and esophageal pressures. (time frame: The outcome will be continuously recorded during the two constant workload exercise testing. The 2 tests will be performed the same day for a total time frame of 3hours.). 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 17 Mar 2022.