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Completed

NCT Number: NCT03174210

Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD

The aim of this study is to investigate the effects of supplemental oxygen on blood oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Germany

About this study

It has been proven that supplemental oxygen increases oxygen saturation and reduces dyspnea in hypoxemic COPD Patients. There are different oxygen delivery systems available, some of them operating with liquid oxygen and others by concentrating the ambient air (concentrators). An advantage of the concentrator system is, that there is no refill required, but only a power plug and plug socket, enabling the patient for higher mobility and to be more autonomous. There are only few publications about whether portable oxygen concentrators have a comparable efficiency on oxygen saturation to liquid oxygen devices with continuous flow (LOD) or not. Until now there are no official recommendations about how to convert the oxygen flow rate for LOD (liter per minute) into the corresponding level of the POC.

Therefore, we investigate the comparability of the portable oxygen concentrator Activox™ 4L (POC) to a liquid oxygen device (Companion®) in 30 hypoxemic COPD patients at rest.

As a baseline assessment, the patients will receive a bodyplethysmography, blood gas analysis without using supplemental oxygen and an evaluation of the diffusion capacity of the lung for CO.

The study will be conducted on 2 consecutive days. 15 patients will be randomized into two different groups: First group will start with POC and will continue the following day with LOD; The second group will start with LOD and continue with POC (cross-over design). All patients will use the same oxygen devices during the study assessments (LOD: Companion 1000 (CE 0050), Chart Industries Inc., Garfiel Heights, OH, USA; POC: Activox™ 4L, Inovalabs Inc., Texas, USA). On both days of the study, patients will be connected to one of the two systems via nasal cannula for a total time period of 40 minutes, while the patient remains in a sitting position without talking. The oxygen flow rate starts at 1liter/min (LOD) or Level 1 (POC) and will be increased every 10 minutes to the next higher level until the maximum of 4l/min (LOD) or level 4 (POC) is reached. Blood gases were taken and breathing frequency will be recorded at the end of each Oxygen Level.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • COPD patients with hypoxemia at rest (paO2 < 55 or 60 mmHg, according to the recent supplemental oxygen guidelines [Hadringe, M., et al., British Thoracic Society guidelines for home oxygen use in adults. Thorax, 2015. 70 Suppl 1: p. i1-43.]
  • Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
  • Written informed consent

Exclusion criteria

  • The Need of more than 4 Liter/min Oxygen at rest to achieve PaO2 > 55 or 60mmHg
  • Signs of acute exacerbation
  • General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency

Treatment and study plan

liquid oxygen device (LOD)

Device

This oxygen Supplementation is used in special order

Other names: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

portable oxygen concentrator (POC)

Device

This oxygen Supplementation is used in special order

Other names: Activox™ 4L, Inovalabs Inc., Texas, USA

Primary outcomes

  1. Difference between LOD and POC in Partial pressure of oxygen levels

    Time frame: after 10 minutes of each LOD step compared to 10 minutes of each POC step

    PO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)

Secondary outcomes

  1. Difference between LOD and POC in Partial pressure of carbon dioxide levels

    Time frame: after 10 minutes of each LOD step compared to 10 minutes of each POC step

    PCO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)

  2. Change of partial pressure of Oxygen from one POC step to the next step

    Time frame: after 10 minutes of one POC step compared to after 10 minutes of the next POC step

    Change in PO2 values from e.g. POC step 1 to POC step 2, step 2 to 3 etc.

  3. Change of partial pressure of carbon dioxide from one POC step to the next step

    Time frame: after 10 minutes of one POC step compared to after 10 minutes of the next POC step

    Change in PCO2 values between e.g. POC step 1 to POC step 2, step 2 to 3 etc.

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2017
Registry last updated
Feb 15, 2018

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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