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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Bernard Kodosh, MD
- 电话号码：646-501-0119
- 邮箱：Bernard.kadosh@nyulangone.org
研究联系人备份
- 姓名：Derrick Tam
- 电话号码：646-634-5626
- 邮箱：Derrick.tam@nyulangone.org
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between Microcirculation Measures: Microvascular oxygen extraction (Smv02)
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
调查人员
- 首席研究员：Bernard Kodosh, MD、NYU Langone Health
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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