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

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ClinicalTrials.gov Identifier: NCT01575327
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date March 14, 2018
Study Start Date  ICMJE July 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
Change in Endurance time [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ]
Duration during the endurance shuttle walking test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 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 disconfort 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 Capnia 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Oxygen Therapy
  • Hypercapnia
Intervention  ICMJE
  • 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
  • Device: Manual settings with FreeO2 system in collection mode
    FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters
Study Arms  ICMJE
  • Active Comparator: Fixed oxygen flow delivery
    Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.
    Intervention: Device: Manual settings with FreeO2 system in collection mode
  • 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.
    Intervention: Device: Automated settings on the oxygen delivery device
Publications * Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pépin JL. Automated O(2) titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
12
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575327
Other Study ID Numbers  ICMJE 11-AGIR-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AGIR à Dom
Study Sponsor  ICMJE AGIR à Dom
Collaborators  ICMJE University Hospital, Grenoble
Investigators  ICMJE
Principal Investigator: Jean-Louis Pepin, MD, PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
PRS Account AGIR à Dom
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP