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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by AGIR à Dom
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01575327
First received: March 13, 2012
Last updated: June 13, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    Duration during the endurance shuttle walking test


Secondary Outcome Measures:
  • Change in Dyspnea during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test

  • Hypercapnia level at baseline [ Time Frame: Day 0 (inclusion) - baseline evaluation ] [ Designated as safety issue: No ]
    Blood gases at rest

  • Change in Cardiac frequency during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pulse oxygen saturation during the endurance shuttle walking test


Estimated Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575327

Contacts
Contact: Jean-Louis Pepin, MD, PhD 0476765516 JPepin@chu-grenoble.fr
Contact: Isabelle Vivodtzev, PhD 0476510304 i.vivodtzev@agiradom.com

Locations
France
Hopital Universitaire Recruiting
Grenoble, France
Contact: Jean-Louis Pepin, MD, PhD    0476765516    JPepin@chu-grenoble.fr   
Contact: Isabelle , Vivodtzev, PhD    0476510304    i.vivodtzev@agiradom.com   
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

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01575327     History of Changes
Other Study ID Numbers: 11-AGIR-01
Study First Received: March 13, 2012
Last Updated: June 13, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 28, 2014