High Flow Nasal Cannula on Exercise Endurance in COPD

Study Overview
=================
Brief Summary
-----------------
Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.

Detailed Description
-----------------
This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).

Official Title
-----------------
Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: high flow nasal cannula
* Device: nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with diagnosis of COPD OPD patients has no AE (within 1 month) not receiving any O2 therapy at home no smoking or quick Exclusion Criteria: fever unstable hemodynamics at resting orthopadeic or neurologic problems that limited exercise

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high flow nasal cannula<br>Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device. | Device: high flow nasal cannula<br>* High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.<br>|
| Active Comparator: nasal cannula<br>Subjects perform a constant-load exercise test with nasal cannula oxygen device. | Device: nasal cannula<br>* Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise time with high flow nasal cannula | the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device | end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device | 
| exercise time with nasal cannula | the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device | end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in cardiac output | Difference in end-exercise cardiac output in constant-load exercise test between HFNCO and NC | Baseline and 48 hours after baseline ] | 
| Difference in stroke volume | Difference in end-exercise stroke volume in constant-load exercise test between HFNCO and NC | Baseline and 48 hours after baseline ] | 
| Difference in muscle tissue oxygenation | Difference in end-exercise muscle tissue oxygenation in constant-load exercise test between HFNCO and NC | Baseline and 48 hours after baseline ] | 
| Difference in cerebral tissue oxygenation | Difference in end-exercise cerebral tissue oxygenation in constant-load exercise test between HFNCO and NC | Baseline and 48 hours after baseline ] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High flow nasal cannula oxygen, exercise performance, COPD