Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
2017年5月19日 更新者：Kevin Kuo、University of Michigan
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- C.S. Mott Children's Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1个月 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：Tissue oxygenation monitoring
|
The device provides continuous measures with updates based on the previous 10 seconds worth of data.
Data is continuously stored.
其他名称：
|
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 |
|---|---|---|
|
tissue oxygenation level as measured by raman spectroscopy device
大体时间：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.
|
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Microcirculation as recorded by sublingual video microcirculation recorder.
大体时间：Twice in the first 24 hours after PICU admission
|
Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.
|
Twice in the first 24 hours after PICU admission
|
|
Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
大体时间：Continuous from PICU admission through 24 hours of admission
|
Bioinformatically enabled armband monitor (BEAM) will be placed on the patient's upper extremity for the first 24 hours of their admission and will be subsequently removed.
The data will be stored in the device and investigators and clinicians caring for subjects will be blinded to the device output as data is collected.
The device continually captures physiologic data such as heart rate, ECG results, and temperature.
|
Continuous from PICU admission through 24 hours of admission
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kevin Ward, MD、University of Michigan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2014年11月1日
研究注册日期
首次提交
2012年12月28日
首先提交符合 QC 标准的
2012年12月28日
首次发布 (估计)
2013年1月3日
研究记录更新
最后更新发布 (实际的)
2017年5月23日
上次提交的符合 QC 标准的更新
2017年5月19日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.