Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

Kyrgyzstan

Study Type

Interventional

Intervention

High-flow oxygen therapy (HFOT)

Low-flow oxygen therapy (LFOT)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

National Center of Cardiology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HFOT first then LFOT

LFOT first then HFOT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Heart rate in bpm

Difference in the maximal heart rate assessed by ECG between HFOT vs. LFOT at the end of exercise.

Arterial blood pressure in mmHg

Difference in the maximal blood pressure between HFOT vs. LFOT at the end of exercise.

Full Information

NCT ID

NCT03955770

First Posted

May 16, 2019

Last Updated

February 5, 2020

Sponsor

University of Zurich

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03955770

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 20, 2019 (Actual)

Primary Completion Date

August 2, 2019 (Actual)

Study Completion Date

August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HFOT first then LFOT

Arm Type

Experimental

Arm Title

LFOT first then HFOT

Arm Type

Experimental

Intervention Type

Combination Product

Intervention Name(s)

High-flow oxygen therapy (HFOT)

Intervention Description

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).

Intervention Type

Combination Product

Intervention Name(s)

Low-flow oxygen therapy (LFOT)

Intervention Description

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 Outcome Measure Information:

Title

Exercise endurance time in seconds

Description

Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.

Time Frame