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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955770
• Other study ID #: 01-8/464-15
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2019
• Est. completion date: August 2, 2019

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• High-flow oxygen therapy (HFOT)
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)
LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise endurance time in seconds	Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary	Dyspnea sensation	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.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary	Subjective leg fatigue sensation	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.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary	Arterial blood gases	Difference of parameters in the arterial blood gases, in particular pH, SaO2, PaO2 and PaCO2 between HFOT vs. LFOT at the end of exercise.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary	Heart rate in bpm	Difference in the maximal heart rate assessed by ECG between HFOT vs. LFOT at the end of exercise.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary	Arterial blood pressure in mmHg	Difference in the maximal blood pressure between HFOT vs. LFOT at the end of exercise.	HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization