COPDNCT04350970
High-flow Nasal Cannula and Exercise Tolerance in COPD
A study testing High flow nasal therapy and Non-invasive ventilation in people with COPD and Rehabilitation, run by Marcelo Alcantara Holanda at 1 site in Brazil.
Trial summary
Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Rehabilitation, Exercise
- What is being tested?
- High flow nasal therapy and Non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to 20 Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous COPD
- FEV1 ≤ 50%
- Optimized medication
Who cannot join
- COPD Exacerbation
- Cardiac disease
- Previous neurologic disorders
- Unable to complete all protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of High-flow Nasal Cannula and Non-invasive Ventilation on Constant-load Exercise Tolerance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. The objective was to evaluate and compare the acute effects of HFNT and NIV during exercise on cardiorespiratory parameters, dyspnea, exercise tolerance and comfort in patients with moderate to severe COPD.
Read the detailed description
The patients underwent an initial clinical examination, with anthropometric evaluation, blood gas analysis, pulmonary function tests and measurement of maximum respiratory pressures. The exercise protocol started in the sector of Ergometry and Cardiopulmonary Exercise Testing. After completing the maximum incremental cardiopulmonary exercise test, two additional visits were scheduled for the three constant load tests. All patients studied underwent an evaluation of cardiopulmonary exercise testing (CPET). During maximum-incremental CPET, breath by breath: oxygen consumption (V̇O2, mL/min), carbon dioxide production (V̇CO2, mL/min), respiratory exchange rate (RER), minute ventilation VE (L/min), respiratory rate (bpm), equivalent ventilation for O2 and CO2 (V̇E/V̇O2 and V̇E/V̇CO2). In addition, cardiac monitoring was performed by 12-lead electrocardiogram (ECG) throughout the procedure. On the day of the experiment, the patients underwent two cardiopulmonary exercises with constant-load at 90% of the previously determined peak, separated by an interval of at least 1 hour.
The NIV parameters were adjusted for each patient with Trilogy 100 (Philips™). Spontaneous ventilation mode was set before the protocol for all patients, and a previous period of NIV adaptation was performed to titrate the inspiratory and expiratory pressures. The adaptation period started with the minimum Inspiratory Positive Airway Pressure (IPAP) value of 15cmH2O, and, every 2 minutes, increasing the pressure every 2 cmH2O according to the patient's tolerance.16 The Expiratory Positive Airway Pressure (EPAP) was programmed to vary between 4 and 6 cmH2O. Before the start of the examination, an adaptation was performed with the selected mask and initial ventilator settings for 20 min. No additional oxygen was offered.
The high flow system used was Optiflow® (Fisher \& Paykel Healthcare, Auckland, New Zealand). Before the test, flow titration was performed for the patient, which started with the administration of a minimum gas flow of 30L/min and, every 2 minutes, the flow was increased by 5L/min according to patient tolerance. The test only started after 20 minutes of adaptation.
- Conditions
- COPD, Rehabilitation, Exercise
- Being tested
- High flow nasal therapy, Non-invasive ventilation, Control
- Keywords
- COPD, High flow nasal therapy, Non-invasive ventilation
- 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.
High flow nasal therapyOther
All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test.
Non-invasive ventilationOther
All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test.
ControlOther
All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The cardiopulmonary exercise test was performed with patient breathing room air. Receives: Other: Control |
| NIV | Active comparator | The cardiopulmonary exercise test was performed with non-invasive ventilation during the test. Receives: Other: Non-invasive ventilation |
| HFNT | Active comparator | The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test. Receives: Other: High flow nasal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise dinamic hyperinflation
To determine the dinamic hyperinflation during exercise test with 3-different situations , Control, NIV and HFNT. During all testes the dinamic hyperinflation will be measured by inspiratory capacity (at rest and at the end o exercise test) and will be demonstrated as porcentage os maximum.
Measured: one week after all tests
Exercise Tolerance
To determine the exercise tolerance with 3-different situations , Control, NIV and HFNT. Time of exercise test will be measured to determine which test could be the best for COPD patients. In additional, the workload will (treadmill inclination and speed) be check to show which intervention has the better response.
Measured: one week after all tests
Secondary outcomes (1)
Dyspnea
To determine the dyspnea during exercise test with 3-different situations , Control, NIV and HFNT. After all situations, Borg scale will be performed to check the dyspnea score at the end of exercise.
Measured: one week after all tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One single COPD group performed 3 differents tests, Control exercise, VNI exercise and HFNT exercise on different days.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo Alcantara Holanda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcelo Alcantara Holanda, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350970
- Sponsor's protocol ID
- 3.009.159
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is study will be submitted to a medical journal.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High-flow Nasal Cannula and Non-invasive Ventilation on Constant-load Exercise Tolerance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04350970
- Acronym / sponsor ID
- 3.009.159
- Conditions
- COPD, Rehabilitation, Exercise
- Keywords
- COPD, High flow nasal therapy, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Marcelo Alcantara HolandaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 17 Apr 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.
Patients with COPD are often unable to sustain a sufficient workload during exercise. The use of external strategies to improve exercise tolerance, such as non-invasive ventilation (NIV) and high-flow nasal therapy (HFNT) have been used. The objective was to evaluate and compare the acute effects of HFNT and NIV during exercise on cardiorespiratory parameters, dyspnea, exercise tolerance and comfort in patients with moderate to severe COPD.
Detailed description
The patients underwent an initial clinical examination, with anthropometric evaluation, blood gas analysis, pulmonary function tests and measurement of maximum respiratory pressures. The exercise protocol started in the sector of Ergometry and Cardiopulmonary Exercise Testing. After completing the maximum incremental cardiopulmonary exercise test, two additional visits were scheduled for the three constant load tests. All patients studied underwent an evaluation of cardiopulmonary exercise testing (CPET). During maximum-incremental CPET, breath by breath: oxygen consumption (V̇O2, mL/min), carbon dioxide production (V̇CO2, mL/min), respiratory exchange rate (RER), minute ventilation VE (L/min), respiratory rate (bpm), equivalent ventilation for O2 and CO2 (V̇E/V̇O2 and V̇E/V̇CO2). In addition, cardiac monitoring was performed by 12-lead electrocardiogram (ECG) throughout the procedure. On the day of the experiment, the patients underwent two cardiopulmonary exercises with constant-load at 90% of the previously determined peak, separated by an interval of at least 1 hour.
The NIV parameters were adjusted for each patient with Trilogy 100 (Philips™). Spontaneous ventilation mode was set before the protocol for all patients, and a previous period of NIV adaptation was performed to titrate the inspiratory and expiratory pressures. The adaptation period started with the minimum Inspiratory Positive Airway Pressure (IPAP) value of 15cmH2O, and, every 2 minutes, increasing the pressure every 2 cmH2O according to the patient's tolerance.16 The Expiratory Positive Airway Pressure (EPAP) was programmed to vary between 4 and 6 cmH2O. Before the start of the examination, an adaptation was performed with the selected mask and initial ventilator settings for 20 min. No additional oxygen was offered.
The high flow system used was Optiflow® (Fisher \& Paykel Healthcare, Auckland, New Zealand). Before the test, flow titration was performed for the patient, which started with the administration of a minimum gas flow of 30L/min and, every 2 minutes, the flow was increased by 5L/min according to patient tolerance. The test only started after 20 minutes of adaptation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One single COPD group performed 3 differents tests, Control exercise, VNI exercise and HFNT exercise on different days.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThe cardiopulmonary exercise test was performed with patient breathing room air. |
| NIV | Active comparator | Other: Non-invasive ventilationThe cardiopulmonary exercise test was performed with non-invasive ventilation during the test. |
| HFNT | Active comparator | Other: High flow nasal therapyThe cardiopulmonary exercise test was performed with a High flow nasal therapy during the test. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous COPD
- FEV1 ≤ 50%
- Optimized medication
Key exclusion criteria (4 listed)
- COPD Exacerbation
- Cardiac disease
- Previous neurologic disorders
- Unable to complete all protocol
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 therapyAll patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test. | Other | HFNT |
| Non-invasive ventilationAll patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test. | Other | NIV |
| ControlAll patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy. | Other | Control |
Primary outcome
Exercise dinamic hyperinflation
Time frame: one week after all tests
To determine the dinamic hyperinflation during exercise test with 3-different situations , Control, NIV and HFNT. During all testes the dinamic hyperinflation will be measured by inspiratory capacity (at rest and at the end o exercise test) and will be demonstrated as porcentage os maximum.
Exercise Tolerance
Time frame: one week after all tests
To determine the exercise tolerance with 3-different situations , Control, NIV and HFNT. Time of exercise test will be measured to determine which test could be the best for COPD patients. In additional, the workload will (treadmill inclination and speed) be check to show which intervention has the better response.
1 secondary outcome
Dyspnea
Time frame: one week after all tests
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 Apr 2020.
- Individual participant dataSharing planned: No. This is study will be submitted to a medical journal.
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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 High flow nasal therapy and Non-invasive ventilation in people with COPD and Rehabilitation, run by Marcelo Alcantara Holanda 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 3 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 17 Apr 2020. 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?
Exercise dinamic hyperinflation (time frame: one week after all tests). The study lists 2 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 17 Apr 2020.