Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-04-17 @ 11:04 PM
Study NCT ID:
NCT02858960
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula and Exercise in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Study Overview
Official Title:
Comparing Exercise Capacity in Patients With COPD Using High Flow Nasal Cannula Oxygen vs The Venturi Mask
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: