NCT07601828Not yet recruiting
Oxygen Delivery Index (ODIN) Study
A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- May 2026
- Primary completion date
- May 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Heart failure
- NCT number
- NCT07601828
What you commit to
- Study type: Interventional
- Planned participants: 30
- From May 2026 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Liver or kidney transplant patients
Other illness
- Patients with ongoing chronic alcohol use disorder or substance abuse disorder
- Patients with a recent cardiac arrest
- Patients with decisional impairment/ cognitive decline.
Other
- Inability to obtain consent from the patient (including patients who are intubated at time of consent)
- Patients on dialysis
- Patients on home assisted mechanical ventilation (via tracheotomy or noninvasive) or requiring home oxygen.
- Patients with severe neurologic injury or dysfunction.
- Prisoners
Who the study is looking for
- 18 years or older
- Diagnosed with advanced heart failure or cardiogenic shock
- Patient already has a pulmonary artery catheter placed
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.