NCT02150434

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

May 26, 2014

Last Update Submit

May 28, 2014

Conditions

COPDExerciseEndurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)

Keywords

Oxygen therapyHypoxemiaCOPDClosed-loopAutomated titration,

Outcome Measures

Primary Outcomes (1)

  • Time within predefined SpO2 target

    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 Outcomes (1)

  • Exercise tolerance

    duration of ESWT

Other Outcomes (1)

  • Physiological parameters

    during ESWT

Study Arms (3)

Compressed Air

SHAM COMPARATOR

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

Drug: Compressed air

Oxygen constant flow

ACTIVE COMPARATOR

oxygen delivered at a fixed flow of 2L/min

Drug: Oxygen constant flow

Automated oxygen titration

EXPERIMENTAL

oxygen at a variable flows delivered by the FreeO2

Device: Automated oxygen titration

Interventions

Automated oxygen titrationDEVICE

Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)

Also known as: FreeO2 system TM, Oxy'nov.inc
Automated oxygen titration
Compressed airDRUG

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

Also known as: Air
Compressed Air
Oxygen constant flowDRUG

oxygen delivered at a fixed flow of 2L/min

Also known as: Oxygen
Oxygen constant flow

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche de l'IUCPQ

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (1)

  • Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.

    PMID: 27794080DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityHypoxia

Interventions

Compressed AirAirOxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and SuppliesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthChalcogensElementsInorganic ChemicalsGases

Study Officials

  • François Lellouche, MD PhD

    Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

June 1, 2013

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

CA(1)