Clinical trial NCT03955770: Effects of HFOT on Exercise Performance in Patients With COPD. A Randomized, Controlled Trial.
Official title: Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Exercise endurance
High-flow oxygen therapy
Low-flow oxygen therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2019-05-20
Enrollment: 79
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise endurance time in seconds
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary outcomes:
measure: Dyspnea sensation
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
measure: Subjective leg fatigue sensation
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
measure: Arterial blood gases
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
measure: Heart rate in bpm
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
measure: Arterial blood pressure in mmHg
timeFrame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Michael Furian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References:
citation: Bitos K, Furian M, Mayer L, Schneider SR, Buenzli S, Mademilov MZ, Sheraliev UU, Marazhapov NH, Abdraeva AK, Aidaralieva SD, Muratbekova AM, Sooronbaev TM, Ulrich S, Bloch KE. Effect of High-Flow Oxygen on Exercise Performance in COPD Patients. Randomized Trial. Front Med (Lausanne). 2021 Feb 19;7:595450. doi: 10.3389/fmed.2020.595450. eCollection 2020.