Cardiogenic Shock, Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEOxygen Delivery Index (ODIN) Device
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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02) | 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. |
| Correlation between Microcirculation Measures: Functional Capillary Density (FCD) | 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. |
| Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV) | 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. |
Contacts
CONTACTBernard Kodosh, MD
CONTACTDerrick Tam
PRINCIPAL_INVESTIGATORBernard Kodosh, MD
NYU Langone Health
Outcome results
None listed