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

March 5, 2014 updated by: Aina M Yañez, Hospital Son Espases

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: combined system
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.
Device: 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)
Experimental: single system
Inogen One G2 portable concentrator (Inogen)
Device: Inogen
single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Espases

Collaborators

Linde AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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