Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.

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

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-03-31

Brief Summary

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Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.

Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4 years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Patients were maintained on the previous combined system for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was monitored

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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combined system

During the first visit, the technician installed a reservoir of liquid oxygen (Liberator 30, Caire) and a liquid Stroller oxygen pack (Caire) for patients using liquid oxygen, or a VisionAire5 (Airsep) stationary concentrator and an Inogen One G2 portable (Inogen) concentrator for patients using concentrators.

Group Type ACTIVE_COMPARATOR

Combination system of a portable and a stationary device.

Intervention Type DEVICE

Combination system of a portable and a stationary device (reservoir of liquid oxygen "Liberator 30, Caire" and a liquid Stroller oxygen pack "Caire" for patients using previously liquid oxygen, or a VisionAire5 "Airsep" stationary concentrator and an Inogen One G2 portable "Inogen" concentrator for patients using previously concentrators)

single system

Inogen One G2 portable concentrator (Inogen)

Group Type EXPERIMENTAL

Inogen

Intervention Type DEVICE

single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours

Interventions

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Inogen

single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours

Intervention Type DEVICE

Combination system of a portable and a stationary device.

Combination system of a portable and a stationary device (reservoir of liquid oxygen "Liberator 30, Caire" and a liquid Stroller oxygen pack "Caire" for patients using previously liquid oxygen, or a VisionAire5 "Airsep" stationary concentrator and an Inogen One G2 portable "Inogen" concentrator for patients using previously concentrators)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 40-80 years
* had been diagnosed with COPD following the GOLD criteria
* were receiving oxygen therapy using a fixed oxygenation system and a portable system for ambulation
* without exacerbation during the previous month
* agreed to participate

Exclusion Criteria

* terminally ill
* unable to understand Spanish
* had high oxygen flow at rest (\> 3 lpm)
* high respiratory frequency at rest (\> 32 rpm)
* were not achieving adequate O2 saturation levels during titration with the portable oxygen source
* had previously been diagnosed with obstructive sleep apnea hypopnea syndrome (SAHS)
* were receiving mechanical ventilation.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No