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

14. februar 2018 opdateret af: Klaus Kenn, Schön Klinik Berchtesgadener Land

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

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®).

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

      • Schoenau Am Koenigssee, Tyskland
        • Schoen Klinik Berchtesgadener Land

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: COPD patients with delivery order 1, 2
Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))
This oxygen Supplementation is used in special order
Andre navne:
  • Companion 1000 Chart Industries, Inc. Garfield Heights, USA
This oxygen Supplementation is used in special order
Andre navne:
  • Activox™ 4L, Inovalabs Inc., Texas, USA
Eksperimentel: COPD patients with delivery order 2,1
Patients will use two different Oxygen devices at rest (1. portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))
This oxygen Supplementation is used in special order
Andre navne:
  • Companion 1000 Chart Industries, Inc. Garfield Heights, USA
This oxygen Supplementation is used in special order
Andre navne:
  • Activox™ 4L, Inovalabs Inc., Texas, USA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between LOD and POC in Partial pressure of oxygen levels
Tidsramme: 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)
after 10 minutes of each LOD step compared to 10 minutes of each POC step

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between LOD and POC in Partial pressure of carbon dioxide levels
Tidsramme: 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)
after 10 minutes of each LOD step compared to 10 minutes of each POC step
Change of partial pressure of Oxygen from one POC step to the next step
Tidsramme: 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.
after 10 minutes of one POC step compared to after 10 minutes of the next POC step
Change of partial pressure of carbon dioxide from one POC step to the next step
Tidsramme: 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.
after 10 minutes of one POC step compared to after 10 minutes of the next POC step

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2017

Primær færdiggørelse (Faktiske)

15. september 2017

Studieafslutning (Faktiske)

15. september 2017

Datoer for studieregistrering

Først indsendt

30. maj 2017

Først indsendt, der opfyldte QC-kriterier

30. maj 2017

Først opslået (Faktiske)

2. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ActivoxTitration

Plan for individuelle deltagerdata (IPD)

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