Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy
Brief summary
This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on cycling endurance in patients with COPD. Each patient will perform two constant load cycling exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively, according to randomization. The load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device.
Interventions
COMBINATION_PRODUCTHigh-flow oxygen therapy (HFOT)
HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher&Paykel, New Zealand).
COMBINATION_PRODUCTLow-flow oxygen therapy (LFOT)
LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).
Sponsors
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC \<0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 \<6 kPa at 760 m) who live \<800 m will be invited.
Exclusion criteria
COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92%), current heavy smoking (\>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise endurance time in seconds | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea sensation | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference in the exercise induced dyspnea sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 no dyspnea at all to 10 Maximum of dyspnea assessed at the end of exercise. |
| Subjective leg fatigue sensation | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference in the exercise induced subjective leg fatigue sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 no leg fatigue at all to 10 Maximum of leg fatigue assessed at the end of exercise. |
| Arterial blood gases | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference of parameters in the arterial blood gases, in particular pH, SaO2, PaO2 and PaCO2 between HFOT vs. LFOT at the end of exercise. |
| Heart rate in bpm | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference in the maximal heart rate assessed by ECG between HFOT vs. LFOT at the end of exercise. |
| Arterial blood pressure in mmHg | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | Difference in the maximal blood pressure between HFOT vs. LFOT at the end of exercise. |
Countries
Kyrgyzstan
Outcome results
None listed