Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia. The study was designed to test the following hypotheses: As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia. As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia. As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Detailed Description
-----------------
Background: In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1 L/min to the baseline oxygen flow during exertion, a new closed-loop system (FreeO2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (SpO2), end-tidal CO2 (EtCO2) and respiratory rate. A preliminary study showed significant improvement in exercise tolerance in COPD patients not needing oxygen therapy. Although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe COPD. Aim of this study is to evaluate this system during endurance shuttle walking test in COPD patients with oxygen therapy and hypercapnia. Methods: The investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Official Title
-----------------
Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia

Conditions
-----------------
COPD, Oxygen Therapy, Hypercapnia

Intervention / Treatment
-----------------
* Device: Automated settings on the oxygen delivery device
* Device: Manual settings with FreeO2 system in collection mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 Years and older Patient with COPD severe to very severe requiring long-term Oxygen Therapy Hypercapnia (PaCO2 > 45mmHg) Former or current smoker greater than or equal to 10 pack-years Exclusion Criteria: Pregnant or breast-feed woman Patients under guardianship Imprisoned patients

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed oxygen flow delivery<br>Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment. | Device: Manual settings with FreeO2 system in collection mode<br>* FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters<br>|
| Experimental: FreeO2 system<br>FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in a closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs. | Device: Automated settings on the oxygen delivery device<br>* FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endurance time | Duration during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dyspnea during ESWT | Visual analogic scores of dyspnea during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 
| Change in Muscle fatigue during ESWT | Visual analogic scores of leg discomfort during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 
| Change in Respiratory frequency during ESWT | Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 
| Change in PaCO2 during ESWT | EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 
| Hypercapnia level at baseline | Blood gases at rest | Day 0 (inclusion) - baseline evaluation | 
| Change in Cardiac frequency during ESWT | Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 | 
| Change in SpO2 during ESWT | Pulse oxygen saturation during the endurance shuttle walking test | Day 0 (inclusion) + 14 and D0 +21 |