Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Inogen
Combination system of a portable and a stationary device.
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, portable concentrator, oxygen sources
Eligibility Criteria
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.
Sites / Locations
- Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
combined system
single system
Arm Description
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.
Inogen One G2 portable concentrator (Inogen)
Outcomes
Primary Outcome Measures
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.
Percentage of time desaturated below 90% using single oxygenation system
Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
Secondary Outcome Measures
Full Information
NCT ID
NCT02079753
First Posted
February 27, 2014
Last Updated
March 5, 2014
Sponsor
Hospital Son Espases
Collaborators
Linde AG
1. Study Identification
Unique Protocol Identification Number
NCT02079753
Brief Title
Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.
Official Title
Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Son Espases
Collaborators
Linde AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, portable concentrator, oxygen sources
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined system
Arm Type
Active Comparator
Arm Description
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.
Arm Title
single system
Arm Type
Experimental
Arm Description
Inogen One G2 portable concentrator (Inogen)
Intervention Type
Device
Intervention Name(s)
Inogen
Intervention Description
single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours
Intervention Type
Device
Intervention Name(s)
Combination system of a portable and a stationary device.
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of time desaturated below 90% when using a combined oxygenation system
Description
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.
Time Frame
at day 7
Title
Percentage of time desaturated below 90% using single oxygenation system
Description
Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
Time Frame
day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25425710
Citation
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.
Results Reference
derived
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Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.
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