Oxygen Delivery Index (ODIN) Study (NCT07601828) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Oxygen Delivery Index (ODIN) Study
30 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)
Timeframe: Up to Day 5
2
Correlation between Microcirculation Measures: Functional Capillary Density (FCD)
Timeframe: Up to Day 5
3
Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV)