Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

Not Applicable

Recruiting

• Conditions: COPD
• Interventions: Device: Nasal High Flow Cannula; Device: Nasal Low Flow Cannula

• Registration Number: NCT06578156
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-29
• Status Verified: 2024-12
• Study Start: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal Low Flow Cannula	Nasal High 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
Nasal Low Flow Cannula	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
Nasal High Flow Cannula	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
Nasal High Flow Cannula	Nasal Low 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

Primary Outcome Measures

Name	Time	Method
6-minute walk test	30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Breathing measured by the Borg dyspnea scale	30 minutes	This 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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States