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Oxygen Delivery Index (ODIN) Study

NCT07601828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bernard Kodosh, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2028-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07601828 on ClinicalTrials.gov