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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: Inogen; Device: Combination system of a portable and a stationary device.

• Registration Number: NCT02079753
• Lead Sponsor: Hospital Son Espases

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-02
• Study First Submitted: 2014-02-27
• Status Verified: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-03-05
• Last Update Submitted: 2014-03-05
• Study First Posted: 2014-03-06
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
single system	Inogen	Inogen One G2 portable concentrator (Inogen)
combined system	Combination system of a portable and a stationary device.	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.

Primary Outcome Measures

Name	Time	Method
Percentage of time desaturated below 90% using single oxygenation system	day 14	Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
Percentage of time desaturated below 90% when using a combined oxygenation system	at day 7	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.

Trial Locations

Locations (1)

Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid; 🇪🇸 Madrid, Spain