Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease (FreeO2-rehab)

AGIR à Dom

Status: Completed

Conditions: Hypercapnia; Oxygen Therapy; COPD

Treatments: Device: Automated settings on the oxygen delivery device; Device: Manual settings with FreeO2 system in collection mode

Study type: Interventional

Funder types: Other

Identifiers

NCT01575327

11-AGIR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Fixed oxygen flow delivery

Active Comparator group

Description:

Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.

Treatment:

Device: Manual settings with FreeO2 system in collection mode

FreeO2 system

Experimental group

Description:

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.

Treatment:

Device: Automated settings on the oxygen delivery device