Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2016 |
| First Submitted: | 03/12/2012 |
| Estimated Enrollment Submitted: | 04/09/2012 |
| First Posted: | 04/10/2012 |
| Last Update Submitted: | 03/12/2018 |
| Last Update Posted: | 03/13/2018 |
| Actual Study Start Date: | 06/30/2012 |
| Estimated Primary Completion Date: | 05/31/2016 |
| Estimated Study Completion Date: | 05/31/2016 |
Condition or disease
Intervention/treatment
Device: FreeO2 system
Device: Fixed oxygen flow delivery
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Fixed oxygen flow delivery Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment. | Device: Fixed oxygen flow delivery FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters |
| Experimental: FreeO2 system 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: FreeO2 system FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in Endurance time [Day 0 (inclusion) + 14 and D0 +21]
Secondary Outcome Measures
1. Change in Dyspnea during ESWT [Day 0 (inclusion) + 14 and D0 +21]
2. Change in Muscle fatigue during ESWT [Day 0 (inclusion) + 14 and D0 +21]
3. Change in Respiratory frequency during ESWT [Day 0 (inclusion) + 14 and D0 +21]
4. Change in PaCO2 during ESWT [Day 0 (inclusion) + 14 and D0 +21]
5. Hypercapnia level at baseline [Day 0 (inclusion) - baseline evaluation]
6. Change in Cardiac frequency during ESWT [Day 0 (inclusion) + 14 and D0 +21]
7. Change in SpO2 during ESWT [Day 0 (inclusion) + 14 and D0 +21]
