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

NCT ID: NCT03955770

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2019-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HFOT first then LFOT

Group Type EXPERIMENTAL

High-flow oxygen therapy (HFOT)

Intervention Type 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)

Intervention Type 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).

LFOT first then HFOT

Group Type EXPERIMENTAL

High-flow oxygen therapy (HFOT)

Intervention Type 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)

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type COMBINATION_PRODUCT

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).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Furian, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Konrad E Bloch, MD

Role: STUDY_CHAIR

University of Zurich

Talant M Sooronbaev, MD

Role: STUDY_DIRECTOR

National Center of Cardiology and Internal Medicine, Bishkek

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Center of Cardiology and Internal Medicine

Bishkek, , Kyrgyzstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kyrgyzstan

References

Explore related publications, articles, or registry entries linked to this study.

Bitos K, Furian M, Mayer L, Schneider SR, Buenzli S, Mademilov MZ, Sheraliev UU, Marazhapov NH, Abdraeva AK, Aidaralieva SD, Muratbekova AM, Sooronbaev TM, Ulrich S, Bloch KE. Effect of High-Flow Oxygen on Exercise Performance in COPD Patients. Randomized Trial. Front Med (Lausanne). 2021 Feb 19;7:595450. doi: 10.3389/fmed.2020.595450. eCollection 2020.

Reference Type DERIVED
PMID: 33693009 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01-8/464-15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindful-Breath for People With COPD
NCT07195838 RECRUITING NA