Oxygen Delivery Index (ODIN) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen Delivery Index (ODIN) Device.
- Who it may be relevant to
- Registry conditions: Heart Failure, Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock
Overview
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.
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
Primary outcome measures
- Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02) [Time frame: Up to Day 5]
- Correlation between Microcirculation Measures: Functional Capillary Density (FCD) [Time frame: Up to Day 5]
- Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV) [Time frame: Up to Day 5]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07601828 · 24-01584