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

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ClinicalTrials.gov Identifier: NCT02150434
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Canada Foundation for Innovation
Information provided by (Responsible Party):
Laval University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Exercise Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test) Device: Automated oxygen titration Drug: Compressed air Drug: Oxygen constant flow Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
Study Start Date : November 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: FreeO2 system TM, Oxy'nov.inc




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. Exercise tolerance [ Time Frame: duration of ESWT ]
    Endurance shuttle walking test time and distance


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02150434


Locations
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Canada, Quebec
Centre de recherche de l'IUCPQ
Québec, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Fonds de la Recherche en Santé du Québec
Canada Foundation for Innovation
Investigators
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Principal Investigator: François Lellouche, MD PhD Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02150434    
Other Study ID Numbers: FreeO2-Rehab-1
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014
Keywords provided by Laval University:
Oxygen therapy
Hypoxemia
COPD
Closed-loop
Automated titration,