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Recruiting NCT06578156

Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal High Flow Cannula, Nasal Low Flow Cannula.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device 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
  • Device 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 measures

  • 6-minute walk test [Time frame: 30 minutes]
Secondary outcome measures (1)
  • Breathing measured by the Borg dyspnea scale [Time frame: 30 minutes]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06578156 · 20240476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗