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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Combination Product: High-flow oxygen therapy (HFOT); Combination Product: Low-flow oxygen therapy (LFOT)

• Registration Number: NCT03955770
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study Start: 2019-05-20
• Study First Posted: 2019-05-20
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LFOT first then HFOT	Low-flow oxygen therapy (LFOT)	-
HFOT first then LFOT	High-flow oxygen therapy (HFOT)	-
HFOT first then LFOT	Low-flow oxygen therapy (LFOT)	-
LFOT first then HFOT	High-flow oxygen therapy (HFOT)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

National Center of Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan