Trial | NCT02150434  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxygen ...

  • Study Participants

    16
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 Started
Nov 30
2009
Primary Completion
May 31
2012
Study Completion
Jun 30
2013
Last Update
May 29
2014
Estimate

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

Drug Compressed air

compressed air delivered at a fixed flow of 2 L/min

  • Other names: Air

Drug Oxygen constant flow

oxygen delivered at a fixed flow of 2L/min

  • Other names: Oxygen

Compressed Air Sham Comparator

compressed air delivered at a fixed flow of 2 L/min

Oxygen constant flow Active Comparator

oxygen delivered at a fixed flow of 2L/min

Automated oxygen titration Experimental

oxygen at a variable flows delivered by the FreeO2

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
No Results Posted