- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04350970
High-flow Nasal Cannula and Exercise Tolerance in COPD
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
CE
-
Fortaleza, CE, Brasilien, 60.430-370
- Federal University of Ceará
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Previous COPD
- FEV1 ≤ 50%
- Optimized medication
Exclusion Criteria:
- COPD Exacerbation
- Cardiac disease
- Previous neurologic disorders
- Unable to complete all protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control
The cardiopulmonary exercise test was performed with patient breathing room air.
|
All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload.
The control test was performed with no additional therapy.
|
|
Aktiv komparator: NIV
The cardiopulmonary exercise test was performed with non-invasive ventilation during the test.
|
All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload.
The NIV was used during all exercise test.
|
|
Aktiv komparator: HFNT
The cardiopulmonary exercise test was performed with a High flow nasal therapy during the test.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise dinamic hyperinflation
Tidsramme: 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.
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one week after all tests
|
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Exercise Tolerance
Tidsramme: 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.
|
one week after all tests
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dyspnea
Tidsramme: one week after all tests
|
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.
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one week after all tests
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 3.009.159
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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