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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: The Venturi Mask; Device: High Flow Nasal Cannula Oxygen

• Registration Number: NCT02858960
• Lead Sponsor: Hospital Italiano de Buenos Aires

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

Study Timeline

• Study First Submitted: 2016-03-29
• Study Start: 2016-04
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
The Venturi Mask	The Venturi Mask	1. Incremental Load Treadmill Test (ILTT) using venturi mask 2. Constant Treadmill Load Test (CTLT) using venturi mask
High Flow Nasal Cannula Oxygen	High Flow Nasal Cannula Oxygen	1. Incremental Load Treadmill Test (ILTT) using HFNCO 2. Constant Treadmill Load Test (CTLT) using HFNCO

Primary Outcome Measures

Name	Time	Method
Exercise capacity - Maximum Walking Speed Reached	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	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.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina