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Completed

NCT Number: NCT02150434

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

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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test) Exercise Hypoxia Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'IUCPQ

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated oxygen titration

Device

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

Compressed air

Drug

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

Other names: Air

Oxygen constant flow

Drug

oxygen delivered at a fixed flow of 2L/min

Other names: Oxygen

Primary outcomes

  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 outcomes

  1. Exercise tolerance

    Time frame: duration of ESWT

    Endurance shuttle walking test time and distance

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Acronym: FreeO2rehab

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 29, 2014
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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