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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02150434
Acronym
FreeO2rehab
Enrollment
16
Registered
2014-05-29
Start date
2009-11-30
Completion date
2013-06-30
Last updated
2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Exercise, Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)

Keywords

Oxygen therapy, Hypoxemia, COPD, Closed-loop, Automated titration,

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.

Interventions

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

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

DRUGOxygen constant flow

oxygen delivered at a fixed flow of 2L/min

Sponsors

Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Canada Foundation for Innovation
CollaboratorOTHER
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time within predefined SpO2 targetduring 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

MeasureTime frameDescription
Exercise toleranceduration of ESWTEndurance shuttle walking test time and distance

Other

MeasureTime frameDescription
Physiological parametersduring ESWTPhysiological 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026