[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638205":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":20,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":20,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":20,"enrollmentInfo":45,"targetDuration":20,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":20,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Advanced Heart Failure or Cardiogenic Shock","EXPERIMENTAL","Participation will last from pre-ODI-Tech measurement, through the start of hospital admission to 5 days, excluding holidays and weekends, while an inpatient. Measurements of the ODIN and assessment of the microcirculation are obtained at bedside, by using a handheld digital microscope and a spectroscopy probe placed lightly at the level of the foveola radialis on the wrist.",[13],"Device: Oxygen Delivery Index (ODIN) Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.\n\nThe 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 expressed as Microvascular Oxygen Saturation (SmvO2) as a measure of microvascular oxygen delivery.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Bernard Kodosh, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","646-501-0119","Bernard.kadosh@nyulangone.org",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Derrick Tam","646-634-5626","Derrick.tam@nyulangone.org",{"type":35,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100638205","oxygen-delivery-index-odin-study-100638205",false,"NCT07601828","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","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with advanced heart failure or cardiogenic shock\n* Patient already has a pulmonary artery catheter placed\n\nExclusion Criteria:\n\n* Inability to obtain consent from the patient (including patients who are intubated at time of consent)\n* Liver or kidney transplant patients\n* Patients on dialysis\n* Patients with ongoing chronic alcohol use disorder or substance abuse disorder\n* Patients on home assisted mechanical ventilation (via tracheotomy or noninvasive) or requiring home oxygen.\n* Patients with a recent cardiac arrest\n* Patients with severe neurologic injury or dysfunction.\n* Prisoners\n* Patients with decisional impairment\u002F cognitive decline.","ALL","18 Years",{"count":46,"type":47},30,"ESTIMATED","INTERVENTIONAL",[50],"NA","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.\n\nThis 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.\n\nThirty consecutive patients will be enrolled upon hospital presentation, undergoing ODIN measurement alongside standard clinical assessments.\n\nODI 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.",[53,54],"Heart Failure","Cardiogenic Shock","NOT_YET_RECRUITING","2026-05-18",{"date":58,"type":59},"2026-05-22","ACTUAL",{"date":61,"type":47},"2026-05",{"date":63,"type":47},"2028-05",{"name":5,"class":6}]