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High Flow Nasal Cannula and Exercise in Chronic Obstructive Pulmonary Disease (COPD)

Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02858960
Enrollment
28
Registered
2016-08-08
Start date
2016-04-30
Completion date
2017-04-30
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

High Flow Nasal Cannula, COPD, Pulmonary rehabilitation, HFNC, Oxygen

Brief summary

The aim of this study is to compare exercise capacity in COPD patients through two different systems of supplemental oxygen delivery: High Flow Nasal Cannula Oxygen (HFNCO) and The Venturi Mask (VM).

Detailed description

Design: interventional, crossover, randomized. The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using two different oxygen delivery devices (High Flow Nasal Cannula Oxygen and The Mask Venturi). Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using HFNCO and the other time with The VM. In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA. The following variables will be measured before, during and after each test: 1. Max speed reached in an Incremental load test: Km/h 2. Max time tolerate in a Constant Load Test: in seconds 3. Oxygen saturation: % 4. Dyspnea: Modified Borg scale (0-10) 5. Cardiac rate: beats per minute 6. Respiratory rate: breaths per minute 7. Blood pressure: mmHg 8. Lower limbs fatigue: modified Borg scale (0-10) 9. Global comfort according to the device used: visual analogue scale (VAS) 0-10

Interventions

Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.

Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.

Sponsors

Hospital Italiano de Buenos Aires
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Long term oxygen therapy (LTOT) or oxygen needs during exercise. * Clinically stable defined as four weeks without exacerbation.

Exclusion criteria

* Refusal to participate * Any neuromuscular or cardiovascular or condition that limits test performance. * Contraindication for exercise

Design outcomes

Primary

MeasureTime frameDescription
Exercise capacity - Maximum Walking Speed Reached2 measurements separated by 48 hsThe exercise capacity test measures the maximum speed (in Km/h) reached during an Incremental Load Treadmill Test (ILTT). The test begins at a speed of 3 km/h and each minute after, we will increase the speed by 0.5 km/h. The patient will walk until he exhausts his capacity, once reached, the test will finished. A second Incremental Load Treadmill Test (ILTT) will be conducted 48 hs afterwards using The Venturi Mask or High Flow Nasal Cannula Oxygen depending on the previous randomization.
Exercise capacity - Maximum Walking Time Reached2 measurements separated by 48 hsThe exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT). The treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT). The patient will walk at the same velocity until he exhausts his capacity thus ending the test. A second Constant Load Treadmill Test (CLTT) will be conducted 48 hs following the first Constant Load Treadmill Test (CLTT) using The Venturi Mask or High Flow Nasal Cannula depending on the previous randomization.

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026