Oxygen Delivery Index (ODIN) Study

Официальное название

A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02) [Срок оценки: Up to Day 5]
• Correlation between Microcirculation Measures: Functional Capillary Density (FCD) [Срок оценки: Up to Day 5]
• Correlation between Microcirculation Measures: Capillary Flow Velocity (CFV) [Срок оценки: Up to Day 5]

Критерии участия

Критерии включения

• 18 years or older
• Diagnosed with advanced heart failure or cardiogenic shock
• Patient already has a pulmonary artery catheter placed

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07601828 · 24-01584

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗