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Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06578156
Enrollment
45
Registered
2024-08-29
Start date
2024-12-12
Completion date
2027-12-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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.

Interventions

DEVICENasal 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

DEVICENasal 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

Sponsors

University of Miami
Lead SponsorOTHER
American Thoracic Society
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
6-minute walk test30 minutesThe object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.

Secondary

MeasureTime frameDescription
Breathing measured by the Borg dyspnea scale30 minutesThis is a patient self-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, where "0" indicated no difficulty breathing, and "10" indicates a maximal breathing difficulty.

Countries

United States

Contacts

CONTACTSaramaria Afanador Castiblanco, M.D.
saramaria.afanador@miami.edu305-243-2568
PRINCIPAL_INVESTIGATORSaramaria Afanador Castiblanco, M.D.

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026