Oxygen Delivery Index (ODIN) Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
18 years or older
Diagnosed with advanced heart failure or cardiogenic shock
Patient already has a pulmonary artery catheter placed
Disqualifiers
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
Trial design
Treatments tested in this trial
- Oxygen Delivery Index (ODIN) Device
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov