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

March 13, 2018 updated by: AGIR à Dom

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • Hopital Universitaire
      • Nyons, France, 26110
        • Centre ATRIR
      • Saint-Julien-de-Raz, France, 38134
        • Centre Henri BAZIRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fixed oxygen flow delivery
Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.
Device: Manual settings with FreeO2 system in collection mode
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: Automated settings on the oxygen delivery device
FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGIR à Dom

Collaborators

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-AGIR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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