Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- tissue oxygenation level as measured by raman spectroscopy device
研究概览
简要总结
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.
详细描述
Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter. Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 30 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
- •Age >30 days and <18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava
排除标准
- •Age <30 days or >18 years
- •Known pregnancy or subsequently discovered pregnancy after admission
- •Uncorrected cyanotic congenital heart disease
- •Relative Exclusion Criteria:
- •Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
- •Upper extremity trauma preventing placement of BEAM device
结局指标
主要结局
tissue oxygenation level as measured by raman spectroscopy device
时间窗: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.
Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.
次要结局
- Microcirculation as recorded by sublingual video microcirculation recorder.(Twice in the first 24 hours after PICU admission)
- Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)(Continuous from PICU admission through 24 hours of admission)
研究者
Kevin Kuo
Fellow, Pediatric Critical Care
University of Michigan