Oxygen Delivery Index (ODIN) Study

NCT07601828 | Not Yet Recruiting

• 1 other identifier: 24-01584
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cardiogenic Shock

Outcome Measures

Primary Outcomes (3)

• Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)

  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)

  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)

  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

Study Arms (1)

Patients with Advanced Heart Failure or Cardiogenic Shock

EXPERIMENTAL

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.

Device: Oxygen Delivery Index (ODIN) Device

Interventions

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.

Patients with Advanced Heart Failure or Cardiogenic Shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Diagnosed with advanced heart failure or cardiogenic shock
• Patient already has a pulmonary artery catheter placed

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

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

Study Officials

• Bernard Kodosh, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard Kodosh, MD

CONTACT

646-501-0119; Bernard.kadosh@nyulangone.org

Derrick Tam

CONTACT

646-634-5626; Derrick.tam@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Bernard.kadosh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.