Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

NCT06578156 | Recruiting FDA Device

• 1 other identifier: 20240476
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  The 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.

  30 minutes

Secondary Outcomes (1)

• Breathing measured by the Borg dyspnea scale

  30 minutes

Study Arms (2)

Nasal High Flow Cannula

EXPERIMENTAL

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

Device: Nasal High Flow Cannula; Device: Nasal Low Flow Cannula

Nasal Low Flow Cannula

ACTIVE COMPARATOR

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

Device: Nasal High Flow Cannula; Device: Nasal Low Flow Cannula

Interventions

Nasal High Flow Cannula 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 High Flow Cannula; Nasal Low Flow Cannula

Nasal Low Flow Cannula 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 High Flow Cannula; Nasal Low Flow Cannula

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• American Thoracic Society: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saramaria Afanador Castiblanco, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saramaria Afanador Castiblanco, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 29, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)