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Effects of HFOT on Exercise Performance in Patients With COPD. A Randomized, Controlled Trial.

University of Zurich (UZH) logo

University of Zurich (UZH)

Status and phase

Completed
Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Combination Product: High-flow oxygen therapy (HFOT)
Combination Product: Low-flow oxygen therapy (LFOT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03955770
01-8/464-15

Details and patient eligibility

About

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).

Full 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.

Enrollment

79 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

79 participants in 2 patient groups

HFOT first then LFOT
Experimental group
Treatment:
Combination Product: High-flow oxygen therapy (HFOT)
Combination Product: Low-flow oxygen therapy (LFOT)
LFOT first then HFOT
Experimental group
Treatment:
Combination Product: High-flow oxygen therapy (HFOT)
Combination Product: Low-flow oxygen therapy (LFOT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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