Oxygen Delivery Index (ODIN) Study

May 18, 2026 updated by: NYU Langone Health

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Oxygen 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Day 5
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.
Up to Day 5
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.
Up to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Bernard Kodosh, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-01584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Bernard.kadosh@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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