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Completed

NCT Number: NCT03955770

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

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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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

About this study

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.

Who can participate

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.

Treatment and study plan

High-flow oxygen therapy (HFOT)

Combination Product

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).

Low-flow oxygen therapy (LFOT)

Combination Product

LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).

Primary outcomes

  1. Exercise endurance time in seconds

    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.

Secondary outcomes

  1. Dyspnea sensation

    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.

  2. Subjective leg fatigue sensation

    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.

  3. Arterial blood gases

    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.

  4. Heart rate in bpm

    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.

  5. Arterial blood pressure in mmHg

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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