Oxygen Delivery Index (ODIN) Study
Starting soon · Not applicable
Conditions studied: Heart Failure, Cardiogenic Shock
In brief
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.
Key facts
- Study ID
- NCT07601828
- Run by
- NYU Langone Health
- People needed
- 30
- Starts
- 2026-05-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 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.
Full record on ClinicalTrials.gov
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