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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Schoenau Am Koenigssee, Alemania
- Schoen Klinik Berchtesgadener Land
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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))
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This oxygen Supplementation is used in special order
Otros nombres:
This oxygen Supplementation is used in special order
Otros nombres:
|
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Experimental: 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
Otros nombres:
This oxygen Supplementation is used in special order
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference between LOD and POC in Partial pressure of oxygen levels
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference between LOD and POC in Partial pressure of carbon dioxide levels
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ActivoxTitration
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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