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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Bernard Kodosh, MD
- Telefoonnummer: 646-501-0119
- E-mail: Bernard.kadosh@nyulangone.org
Studie Contact Back-up
- Naam: Derrick Tam
- Telefoonnummer: 646-634-5626
- E-mail: Derrick.tam@nyulangone.org
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Patients with Advanced Heart Failure or Cardiogenic Shock
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.
|
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 expressed as Microvascular Oxygen Saturation (SmvO2) as a measure of microvascular oxygen delivery. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)
Tijdsspanne: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
Smv02 is defined as the percentage of oxygen remaining in venous blood returning to the lungs.
The Smv02 reading determined by ODIN will be compared with existing methods to determine Smv02 in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
|
Correlation between Microcirculation Measures: Functional Capillary Density (FCD)
Tijdsspanne: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
FCD is defined as number of capillaries that possess red blood cell transit.
The FCD reading determined by ODIN will be compared with existing methods to determine FCD in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
|
Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV)
Tijdsspanne: Up to Day 5
|
This outcome will measure the correlation of ODIN output readings with existing guidelines for hemodynamic assessments and measures.
The CFV reading determined by ODIN will be compared with existing methods to determine CFV in order to evaluate the feasibility and performance of the device.
|
Up to Day 5
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Bernard Kodosh, MD, NYU Langone Health
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 24-01584
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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