Oxygen Delivery Index (ODIN) Study
A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock
The objective of this study is to test the feasibility and efficacy of a novel, non-invasive electronic device to monitor the adequacy of tissue perfusion in patients with advanced heart failure or cardiogenic shock in the ICU.
This single-site pilot study will evaluate the FDA-approved Oxygen Delivery Index (ODIN), a non-invasive method for assessing microvascular function and oxygen extraction, in patients with advanced heart failure and cardiogenic shock. ODIN comprises ODI Technology (including CAM, DRS, a medical PC, and an enclosure), a standardized data acquisition procedure, and proprietary analysis software.
Thirty consecutive patients will be enrolled upon hospital presentation, undergoing ODIN measurement alongside standard clinical assessments.
ODI Tech data are collected solely for research correlation with established diagnostic standards; measurements will not be used to diagnose or contribute to any clinical decision making, and will not be used for any clinical indication or guidance.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bernard Kodosh, MD
- Número de teléfono: 646-501-0119
- Correo electrónico: Bernard.kadosh@nyulangone.org
Copia de seguridad de contactos de estudio
- Nombre: Derrick Tam
- Número de teléfono: 646-634-5626
- Correo electrónico: Derrick.tam@nyulangone.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18 years or older
- Diagnosed with advanced heart failure or cardiogenic shock
- Patient already has a pulmonary artery catheter placed
Exclusion Criteria:
- Inability to obtain consent from the patient (including patients who are intubated at time of consent)
- Liver or kidney transplant patients
- Patients on dialysis
- Patients with ongoing chronic alcohol use disorder or substance abuse disorder
- Patients on home assisted mechanical ventilation (via tracheotomy or noninvasive) or requiring home oxygen.
- Patients with a recent cardiac arrest
- Patients with severe neurologic injury or dysfunction.
- Prisoners
- Patients with decisional impairment/ cognitive decline.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patients with Advanced Heart Failure or Cardiogenic Shock
Participation will last from pre-ODI-Tech measurement, through the start of hospital admission to 5 days, excluding holidays and weekends, while an inpatient.
Measurements of the ODIN and assessment of the microcirculation are obtained at bedside, by using a handheld digital microscope and a spectroscopy probe placed lightly at the level of the foveola radialis on the wrist.
|
Non-invasive, battery powered, portable unit composed of a touch screen and two technologies for data acquisition; computer assisted microscopy (CAM), and diffuse reflectance spectroscopy (DRS) managed by the ODI-Tech mLab software. The microscope provides white light dermoscopic images in the region of interest. Diffuse reflectance spectroscopy (DRS) provides information on oxygen saturation of erythrocytes in subepidermal capillaries, also in measuring volumes of ≈ 0.1mm3. The information is expressed as Microvascular Oxygen Saturation (SmvO2) as a measure of microvascular oxygen delivery. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)
Periodo de tiempo: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
Smv02 is defined as the percentage of oxygen remaining in venous blood returning to the lungs.
The Smv02 reading determined by ODIN will be compared with existing methods to determine Smv02 in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
|
Correlation between Microcirculation Measures: Functional Capillary Density (FCD)
Periodo de tiempo: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
FCD is defined as number of capillaries that possess red blood cell transit.
The FCD reading determined by ODIN will be compared with existing methods to determine FCD in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
|
Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV)
Periodo de tiempo: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
The CFV reading determined by ODIN will be compared with existing methods to determine CFV in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bernard Kodosh, MD, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24-01584
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
producto fabricado y exportado desde los EE. UU.
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