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

Study Overview
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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

Official Title
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Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Inogen
* Device: Combination system of a portable and a stationary device.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: combined system<br>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. | Device: Combination system of a portable and a stationary device.<br>* 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)<br>|
| Experimental: single system<br>Inogen One G2 portable concentrator (Inogen) | Device: Inogen<br>* single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time desaturated below 90% when using a combined oxygenation system | oxygenation of patient during use of a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation. | at day 7 | 
| Percentage of time desaturated below 90% using single oxygenation system | Oxygenation of patient during use of a portable oxygen pulse dose concentrator. | day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, portable concentrator, oxygen sources