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Clinical Trials/NCT02858960
NCT02858960
Completed
Not Applicable

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

Hospital Italiano de Buenos Aires1 site in 1 country28 target enrollmentApril 2016
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Hospital Italiano de Buenos Aires
Enrollment
28
Locations
1
Primary Endpoint
Exercise capacity - Maximum Walking Speed Reached
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
April 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Exercise capacity - Maximum Walking Speed Reached

Time Frame: 2 measurements separated by 48 hs

The 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 Reached

Time Frame: 2 measurements separated by 48 hs

The 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.

Study Sites (1)

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