- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03174210
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Schoenau Am Koenigssee, Tyskland
- Schoen Klinik Berchtesgadener Land
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
This oxygen Supplementation is used in special order
Andre navn:
|
Eksperimentell: 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 navn:
This oxygen Supplementation is used in special order
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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)
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after 10 minutes of each LOD step compared to 10 minutes of each POC step
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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)
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after 10 minutes of each LOD step compared to 10 minutes of each POC step
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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
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Change in PO2 values from e.g.
POC step 1 to POC step 2, step 2 to 3 etc.
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after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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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.
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after 10 minutes of one POC step compared to after 10 minutes of the next POC step
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ActivoxTitration
Plan for individuelle deltakerdata (IPD)
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