Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

NCT ID: NCT06578156

Last Updated: 2024-12-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2027-12-31

Brief Summary

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

This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.

Detailed Description

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

Conditions

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

COPD

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

NONE

Study Groups

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

Nasal High Flow Cannula

Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes

Group Type EXPERIMENTAL

Nasal High Flow Cannula

Intervention Type DEVICE

High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times

Nasal Low Flow Cannula

Intervention Type DEVICE

Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times

Nasal Low Flow Cannula

Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes

Group Type ACTIVE_COMPARATOR

Nasal High Flow Cannula

Intervention Type DEVICE

High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times

Nasal Low Flow Cannula

Intervention Type DEVICE

Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times

Interventions

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

Nasal High Flow Cannula

High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times

Intervention Type DEVICE

Nasal Low Flow Cannula

Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Able to consent
* Age 18 years or older
* Diagnosis of COPD
* Ability to ambulate without assistance
* Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all

Exclusion Criteria

* Pregnancy
* Being on bedrest
* Inability to consent or cooperate with the study
* Using of \> 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
* Hemodynamic instability (resting heart rate \> 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
* Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

American Thoracic Society

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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

Saramaria Afanador Castiblanco

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Saramaria Afanador Castiblanco, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Saramaria Afanador Castiblanco, M.D.

Role: CONTACT

Phone: 305-243-2568

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Saramaria Afanador Castiblanco, M.D.

Role: primary

Other Identifiers

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

20240476

Identifier Type: -

Identifier Source: org_study_id