Pulmonary DiseasesNCT06620081
Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study
A study testing Performance Tests and Functional Tests in people with Pulmonary Diseases and Oxygen Therapy, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Pulmonary Diseases, Oxygen Therapy, High-flow Nasal Cannula
- What is being tested?
- Performance Tests and Functional Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2021to 24 Jul 2024
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes
- Patients on the national lung transplant waiting list
- Chronic obstructive pulmonary disease
- Idiopathic or familial pulmonary fibrosis
- Bronchiectasis
- Sarcoidosis
Who cannot join
- Osteoarticular limitation,
- Neuromuscular disease,
- Anemia
- Hyperglycemia
- Arrhythmia
- Left heart failure
- Pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. The main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. The improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.
Read the detailed description
Introduction: Pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. Rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. The high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. Objectives: To assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. Method: A randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.
- Being tested
- Performance Tests, Functional Tests
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance TestsOther
Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.
Functional TestsOther
Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen therapyHigh flow nasal cannula | Experimental | High-Flow Nasal Cannula Therapy (HFNC Therapy). Receives: Other: Performance Tests; Other: Functional Tests |
| Conventional oxygen therapy | Active comparator | Conventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask. Receives: Other: Performance Tests; Other: Functional Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of HFNC on the distance covered in the 6MWT
Assessment of the distance traveled in 6 minutes.
Measured: 24 months
Effect of HFNC on CO2 kinetics.
Assessment of the kinetics of effort-induced carbon dioxide.
Measured: 24 months
Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.
Assessment of high-flow therapy in effort-induced hyperinflation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start2 Jun 2021
- Primary completion31 Mar 2023
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies 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
- Crossover
- Model description
- This pilot study is a randomized crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Cristina Pereira, Study chair, Albert Einstein Israelite HospitalJosé Eduardo Afonso Júnior, Study chair, Albert Einstein Israelite HospitalMelline Della Torre de Almeida, Study chair, Albert Einstein Israelite HospitalPriscila Borelli Pereira Leite, Study chair, Albert Einstein Israelite HospitalThaise de Lucca Cappeline, Study chair, Albert Einstein Israelite HospitalThaís Melatto Loschi, Study chair, Albert Einstein Israelite HospitalVanuza Ferreira dos Santos, Study chair, Albert Einstein Israelite HospitalLuciana Diniz Nagem Janot de Matos, Study director, Albert Einstein Israelite Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620081
- Sponsor's protocol ID
- 26495219.1.0000.0071
- Status last verified
- Jul 2024
- First submitted
- 6 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Flow Nasal Cannula on Exercise Outcomes in Lung Transplant Candidates: A Pilot Study
- ClinicalTrials.gov ID
- NCT06620081
- Acronym / sponsor ID
- 26495219.1.0000.0071
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 1 Oct 2024 (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 study evaluated patients on the national lung transplant waiting list. It was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. The main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. The improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.
Detailed description
Introduction: Pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. Rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. The high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. Objectives: To assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. Method: A randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. Three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot study is a randomized crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapyHigh flow nasal cannula | Experimental | Other: Performance Tests, Other: Functional TestsHigh-Flow Nasal Cannula Therapy (HFNC Therapy). |
| Conventional oxygen therapy | Active comparator | Other: Performance Tests, Other: Functional TestsConventional Oxygen Therapy with Venturi Mask or Non-Rebreather Mask. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers of both sexes
- Patients on the national lung transplant waiting list
- Chronic obstructive pulmonary disease
- Idiopathic or familial pulmonary fibrosis
- Bronchiectasis
Key exclusion criteria (7 listed)
- Osteoarticular limitation,
- Neuromuscular disease,
- Anemia
- Hyperglycemia
- Arrhythmia
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 |
|---|---|---|
| Performance TestsThree functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces. | Other | Conventional oxygen therapy, Oxygen therapyHigh flow nasal cannula |
| Functional TestsThree functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. Each test was conducted on different days with different devices: HFNC and conventional oxygen therapy, totaling six test days. The inspired oxygen fraction (FiO2) was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces. | Other | Conventional oxygen therapy, Oxygen therapyHigh flow nasal cannula |
Primary outcome
Evaluate the effect of HFNC on the distance covered in the 6MWT
Time frame: 24 months
Assessment of the distance traveled in 6 minutes.
Effect of HFNC on CO2 kinetics.
Time frame: 24 months
Assessment of the kinetics of effort-induced carbon dioxide.
Investigate the effect of HFNC on exercise-induced dynamic hyperinflation in patients on the lung transplant waiting list participating in a cardiopulmonary rehabilitation program.
Time frame: 24 months
Assessment of high-flow therapy in effort-induced hyperinflation.
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 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Elaine Cristina Pereira study chair
Albert Einstein Israelite Hospital
José Eduardo Afonso Júnior study chair
Albert Einstein Israelite Hospital
Melline Della Torre de Almeida study chair
Albert Einstein Israelite Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance Tests and Functional Tests in people with Pulmonary Diseases and Oxygen Therapy, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 6 inclusion and 7 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 1 Oct 2024. 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 Brazil. 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?
Evaluate the effect of HFNC on the distance covered in the 6MWT (time frame: 24 months). The study lists 3 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 1 Oct 2024.