Clinical trial NCT02858960: High Flow Nasal Cannula and Exercise in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: High Flow Nasal Cannula
COPD
Pulmonary rehabilitation
HFNC
Oxygen
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity - Maximum Walking Speed Reached
timeFrame: 2 measurements separated by 48 hs
measure: Exercise capacity - Maximum Walking Time Reached
timeFrame: 2 measurements separated by 48 hs
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Nicolas NR Roux, PT-RT
role: PRINCIPAL_INVESTIGATOR
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