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Completed

NCT Number: NCT02079753

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inogen

Device

single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours

Combination system of a portable and a stationary device.

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)

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital Son Espases

Other

Collaborators

  • Linde AG

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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