COPD, Hypercapnia, Oxygen Therapy
Conditions
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.
Interventions
FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters
FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters
Sponsors
University Hospital, Grenoble
AGIR à Dom
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endurance time | Day 0 (inclusion) + 14 and D0 +21 | Duration during the endurance shuttle walking test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle fatigue during ESWT | Day 0 (inclusion) + 14 and D0 +21 | Visual analogic scores of leg discomfort during the endurance shuttle walking test |
| Change in Respiratory frequency during ESWT | Day 0 (inclusion) + 14 and D0 +21 | Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test |
| Change in PaCO2 during ESWT | Day 0 (inclusion) + 14 and D0 +21 | EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test |
| Change in Dyspnea during ESWT | Day 0 (inclusion) + 14 and D0 +21 | Visual analogic scores of dyspnea during the endurance shuttle walking test |
| Change in Cardiac frequency during ESWT | Day 0 (inclusion) + 14 and D0 +21 | Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test |
| Change in SpO2 during ESWT | Day 0 (inclusion) + 14 and D0 +21 | Pulse oxygen saturation during the endurance shuttle walking test |
| Hypercapnia level at baseline | Day 0 (inclusion) - baseline evaluation | Blood gases at rest |
Countries
France
Outcome results
None listed