Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

University of Miami

Status: Enrolling

Conditions: COPD

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06578156

20240476

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Nasal High Flow Cannula

Experimental group

Description:

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

Treatment:

Device: Nasal High Flow Cannula

Device: Nasal Low Flow Cannula

Nasal Low Flow Cannula

Active Comparator group

Description:

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

Treatment:

Device: Nasal High Flow Cannula

Device: Nasal Low Flow Cannula