Clinical trial NCT02079753: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, portable concentrator, oxygen sources
Lead sponsor: Hospital Son Espases
Sponsor class: OTHER
Collaborators: name: Linde AG
First posted: 2014-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of time desaturated below 90% when using a combined oxygenation system
timeFrame: at day 7
measure: Percentage of time desaturated below 90% using single oxygenation system
timeFrame: day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid
Study officials:
References:
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.