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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02079753
Enrollment
38
Registered
2014-03-06
Start date
2011-06-30
Completion date
2014-03-31
Last updated
2014-03-06

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, portable concentrator, oxygen sources

Brief summary

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

Interventions

DEVICEInogen

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

DEVICECombination 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)

Sponsors

Linde AG
CollaboratorINDUSTRY
Hospital Son Espases
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time desaturated below 90% when using a combined oxygenation systemat day 7oxygenation 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.
Percentage of time desaturated below 90% using single oxygenation systemday 14Oxygenation of patient during use of a portable oxygen pulse dose concentrator.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026