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

Not Applicable

Completed

• Conditions: Hypercapnia; COPD; Oxygen Therapy
• Interventions: Device: Automated settings on the oxygen delivery device; Device: Manual settings with FreeO2 system in collection mode

• Registration Number: NCT01575327
• Lead Sponsor: AGIR à Dom

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.

Study Timeline

• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Study Start: 2012-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FreeO2 system	Automated settings on the oxygen delivery device	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.
Fixed oxygen flow delivery	Manual settings with FreeO2 system in collection mode	Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.

Primary Outcome Measures

Name	Time	Method
Change in Endurance time	Day 0 (inclusion) + 14 and D0 +21	Duration during the endurance shuttle walking test

Secondary Outcome Measures

Name	Time	Method
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 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
Hypercapnia level at baseline	Day 0 (inclusion) - baseline evaluation	Blood gases at rest
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

Trial Locations

Locations (3)

Centre ATRIR; 🇫🇷 Nyons, France

Centre Henri BAZIRE; 🇫🇷 Saint-Julien-de-Raz, France

Hopital Universitaire; 🇫🇷 Grenoble, France