Recruiting

Nasal High Flow

Sponsor:

University of Miami

Code:

NCT06578156

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nasal High Flow Cannula

Nasal Low Flow Cannula

Study Details

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.

Conditions

COPD

Study ID

NCT06578156

Start date

Dec 12, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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)

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: 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

Interventions

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

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

Primary outcome measure

  • 6-minute walk test [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Saramaria Afanador Castiblanco, M.D.

305-243-2568saramaria.afanador@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Saramaria Afanador Castiblanco, M.D.

3052432568saramaria.afanador@miami.edu

Principal Investigator:

Saramaria Afanador Castiblanco, M.D.

More Information

Sponsor

University of Miami

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-22.