Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD (FreeO2rehab)

May 28, 2014 updated by: Laval University
The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V4G5
        • Centre de recherche de l'IUCPQ

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:

  • Patients older than 40 years
  • Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
  • Who did not require long-term oxygen therapy were included in the study.
  • Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise

Exclusion Criteria:

  • Episode of exacerbation or hospitalisation within last four weeks
  • Current medical condition that could influence exercise tolerance

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Compressed Air
compressed air delivered at a fixed flow of 2 L/min
Drug: Compressed air
compressed air delivered at a fixed flow of 2 L/min
Other Names:
  • Air
Active Comparator: Oxygen constant flow
oxygen delivered at a fixed flow of 2L/min
Drug: Oxygen constant flow
oxygen delivered at a fixed flow of 2L/min
Other Names:
  • Oxygen
Experimental: Automated oxygen titration
oxygen at a variable flows delivered by the FreeO2
Device: Automated oxygen titration
Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)
Other Names:
  • FreeO2 system TM, Oxy'nov.inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time within predefined SpO2 target
Time Frame: during exercise (Endurance shuttle walking test)
The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%
during exercise (Endurance shuttle walking test)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise tolerance
Time Frame: duration of ESWT
Endurance shuttle walking test time and distance
duration of ESWT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameters
Time Frame: during ESWT
Physiological parameters continuously recorded by the FreeO2 system (SpO2, end-tidal CO2 [EtCO2], respiratory rate, heart rate and oxygen flow when automated oxygen titration was activated), blood gases (before and after ESWT and after recovery) and dyspnea assessment during ESWT with a 10-point Borg scale
during ESWT

Collaborators and Investigators

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

Sponsor

Laval University

Collaborators

Fonds de la Recherche en Santé du Québec
Canada Foundation for Innovation

Investigators

  • Principal Investigator: François Lellouche, MD PhD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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

November 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FreeO2-Rehab-1

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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