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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Compressed Air

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

Group Type SHAM_COMPARATOR

Compressed air

Intervention Type DRUG

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

Oxygen constant flow

oxygen delivered at a fixed flow of 2L/min

Group Type ACTIVE_COMPARATOR

Oxygen constant flow

Intervention Type DRUG

oxygen delivered at a fixed flow of 2L/min

Automated oxygen titration

oxygen at a variable flows delivered by the FreeO2

Group Type EXPERIMENTAL

Automated oxygen titration

Intervention Type DEVICE

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

Interventions

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Automated oxygen titration

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

Intervention Type DEVICE

Compressed air

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

Intervention Type DRUG

Oxygen constant flow

oxygen delivered at a fixed flow of 2L/min

Intervention Type DRUG

Other Intervention Names

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FreeO2 system TM, Oxy'nov.inc Air Oxygen

Eligibility Criteria

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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