Oxygen Delivery Index (ODIN) Study

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.

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Key information

Conditions

Heart Failure Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen Delivery Index (ODIN) Device

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.

Primary outcomes

Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard Kodosh, MD

CONTACT

[email protected]

646-501-0119

Derrick Tam

CONTACT

[email protected]

646-634-5626

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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