National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
NCT Number: NCT03955770
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).
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Notify Me35 year–75 year
All sexes
Interventional
Phase 4
Bishkek, Kyrgyzstan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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).
LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Zurich
Other
Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.
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