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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079753
• Other study ID #: POCs
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2014
• Last updated: March 5, 2014
• Start date: June 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Inogen
single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours
• Combination system of a portable and a stationary device.
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)

Locations

Country	Name	City	State
Spain	Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Son Espases	Linde AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Percentage of time desaturated below 90% using single oxygenation system	Oxygenation of patient during use of a portable oxygen pulse dose concentrator.	day 14	No