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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575327
First Posted: April 11, 2012
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom
  Purpose

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.


Condition Intervention
COPD Oxygen Therapy Hypercapnia Device: Automated settings on the oxygen delivery device Device: Manual settings with FreeO2 system in collection mode

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Change in Endurance time [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ]
    Duration during the endurance shuttle walking test


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • Hypercapnia level at baseline [ Time Frame: Day 0 (inclusion) - baseline evaluation ]
    Blood gases at rest

  • 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

  • Change in SpO2 during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ]
    Pulse oxygen saturation during the endurance shuttle walking test


Enrollment: 15
Study Start Date: July 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575327


Locations
France
Hopital Universitaire
Grenoble, France
Centre ATRIR
Nyons, France, 26110
Centre Henri BAZIRE
Saint Julien de Ratz, France, 38134
Sponsors and Collaborators
AGIR à Dom
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
  More Information

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01575327     History of Changes
Other Study ID Numbers: 11-AGIR-01
First Submitted: March 13, 2012
First Posted: April 11, 2012
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms