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.
1 other identifier
interventional
38
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedMarch 6, 2014
March 1, 2014
8 months
February 27, 2014
March 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
combined system
ACTIVE COMPARATORDuring 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.
single system
EXPERIMENTALInogen One G2 portable concentrator (Inogen)
Interventions
single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Son Espaseslead
- Linde AGcollaborator
Study Sites (1)
Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid
Madrid, Madrid, 28040, Spain
Related Publications (1)
Yanez AM, Prat JP, Alvarez-Sala JL, Calle M, Diaz Lobato S, Garcia Gonzalez JL, Rodriguez Gonzalez-Moro JM, Galera-Martinez R, Villasante C, Ramos I, Franco-Gay M, de Lucas P. Oxygenation With a Single Portable Pulse-Dose Oxygen-Conserving Device and Combined Stationary and Portable Oxygen Delivery Devices in Subjects With COPD. Respir Care. 2015 Mar;60(3):382-7. doi: 10.4187/respcare.03470. Epub 2014 Nov 25.
PMID: 25425710DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Epidemilogist
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 6, 2014
Study Start
June 1, 2011
Primary Completion
February 1, 2012
Study Completion
March 1, 2014
Last Updated
March 6, 2014
Record last verified: 2014-03