Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02079753
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2014-02-27
Brief Title:
Single Portable Pulse-dose-conserving Device vs Combined Use of Stationary and Portable
Sponsor:
Hospital Son Espases
Organization:
Hospital Son Espases
Study Overview
Official Title:
Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 722 74 years mean FEV 3414 1251 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
Methods This cross-over trial assessed 25 patients with COPD 92 men mean age 722 74 years mean FEV 3414 1251 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None