NCT01575327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 14, 2018

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

March 13, 2012

Last Update Submit

March 13, 2018

Conditions

COPDOxygen TherapyHypercapnia

Outcome Measures

Primary Outcomes (1)

  • Change in Endurance time

    Duration during the endurance shuttle walking test

    Day 0 (inclusion) + 14 and D0 +21

Secondary Outcomes (7)

  • Change in Dyspnea during ESWT

    Day 0 (inclusion) + 14 and D0 +21

  • Change in Muscle fatigue during ESWT

    Day 0 (inclusion) + 14 and D0 +21

  • Change in Respiratory frequency during ESWT

    Day 0 (inclusion) + 14 and D0 +21

  • Change in PaCO2 during ESWT

    Day 0 (inclusion) + 14 and D0 +21

  • Hypercapnia level at baseline

    Day 0 (inclusion) - baseline evaluation

  • +2 more secondary outcomes

Study Arms (2)

Fixed oxygen flow delivery

ACTIVE COMPARATOR

Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.

Device: Manual settings with FreeO2 system in collection mode

FreeO2 system

EXPERIMENTAL

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

Interventions

Automated settings on the oxygen delivery deviceDEVICE

FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters

FreeO2 system
Manual settings with FreeO2 system in collection modeDEVICE

FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters

Fixed oxygen flow delivery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breast-feed woman
  • Patients under guardianship
  • Imprisoned patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Universitaire

Grenoble, France

Location

Centre ATRIR

Nyons, 26110, France

Location

Centre Henri BAZIRE

Saint-Julien-de-Raz, 38134, France

Location

Related Publications (1)

  • Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 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.

    PMID: 30166425DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Jean-Louis Pepin, MD, PhD

    Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

April 11, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 14, 2018

Record last verified: 2017-01

Locations

FR(3)