Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg (FORE-SIGHT)
2017年10月6日 更新者：Anup Katheria, M.D.、Sharp HealthCare
Validation of FORE-SIGHT Cerebral & Tissue Oximeter to Measure Cerebral & Somatic Tissue Oxygen Saturation Measurements at Different Body Locations on Neonates ≤ 5 kg
CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements.
This monitor was recently FDA cleared for use on adult subjects.
研究概览
地位
完全的
详细说明
- Validate FS-II abdominal StO2 measurements from the intestines, liver, and flank to umbilical venous and arterial blood oxygen saturation.
- Validate FS-II cerebral StO2 measurements against the predicate FDA cleared FORE-SIGHT-I (FS-I) monitor.
- Collect data from FS-II sensors on the forehead and abdomen (intestine) for 24 hours to compare dynamic changes vs the pulse oximeter. For larger neonates, add a predicate FS-I sensor to the opposite side forehead for dynamic comparison to FS-II measurements.
- Obtain abdominal Near Infrared Spectroscopy (NIRS) data simultaneous with accepted measures of bowel motility (a. frequency and composition of stools, and b. Ultrasound assessment for the frequency and magnitude of bowel peristalsis, if available).
研究类型
观察性的
注册 (实际的)
19
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
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California
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San Diego、California、美国、92123
- Sharp Mary Birch Hospital for Women and Newborns
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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
不超过 1周 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the NICU.
Demographic information of the subject will be recorded, including race, gender, weight, gestational age (GA), study age, and diagnosis.
描述
Inclusion Criteria:
Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the Neonatal Intensive Care Unit.
Exclusion Criteria:
Enrollment in other studies during study period. Inability to tolerate ultrasounds or NIRS sensors
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
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Preterm Infants
Preterm infants 32 to 36 weeks will be eligible for this study
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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 |
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StO2 measurement from intestines, liver and flank at time of venous and arterial blood oxygen saturation.
大体时间：1 hour
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At or immediately following an umbilical venous blood draw for CO-oximetry, the FS-II NIRS Small sensor will be briefly placed on the abdominal wall for spot check measurements over the 1) left & 2) right flank, 3) liver and on three intestine locations: just inferior and lateral to the umbilicus in the 4) Right Lower Quadrant (RLQ) and 5) Left Lower Quadrant (LLQ) positions, as well as 6) Mid Lower Quadrant (MLQ).
Then a reference FS-I measurement of the 7) flank for 2 minutes will be done.
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1 hour
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Cerebral StO2 measurements from Fore-Sight FS-II monitor and Fore-Sight-I (FS-I) monitor.
大体时间：1 hour
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Following abdominal measurements, the FS-II Small sensor will be placed on the head with the following positions in the following sequence 1) forehead, over the frontal cortex for two minutes; 2) the FS-II sensor is lifted off the head and placed back in the same forehead position to make a repeat measurement for two minutes; and 3) on the side of the head above the ear (frontal and parietal cortex) for two minutes.
For reference cerebral measurements, a FDA cleared FS-I Small sensor will be placed on the 4) forehead for two minutes; 5) the FS-I sensor will be removed and replaced on the same forehead position to make a repeat measurement for two minutes.
The sensors will take a measurement of 2 minutes in each position and 10 minutes total.
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1 hour
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Pulse and Tissue oxygen saturation and infant activity
大体时间：24 hours
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Then two FS-II Small sensors will be attached longer term, one sensor on the forehead and one sensor on the abdomen (RLQ), with neonatal adhesives to allow monitoring for up to 24 hours.
Dynamic changes of StO2 at these locations will be observed, along with pulse oximetry SpO2 to capture any acute events such as apnea and bradycardia, which will help in modeling and verifying dynamic StO2 change behavior within the FS-II algorithm.
FS-II, and pulse oximetry data will be collected simultaneously on a laptop computer.
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24 hours
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Stool Interference Index over 24 hrs.
大体时间：24 hours
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To calculate abdominal StO2 over the intestine regions, FORE-SIGHT also measures a stool interference index, which is used to compensate the algorithm to calculate StO2 correctly.
This stool interference index is hypothesized to be also useful as a bowel motility index based on its variability over time.
To test this hypothesis, the following two references for bowel motility will be tested: a) the study site will minimally record the number of stools for a period up to 24 hours.
The event field in the laptop computer will be used to note each observation.
b) if the study site has the capacity, abdominal ultrasound will be used to observe for the frequency and magnitude of bowel peristalsis.
These impressions will be added to an event field in the laptop computer.
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24 hours
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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：Anuup Katheria, MD、Sharp Mary Birch Hospital for Women & Newborns
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12月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2013年12月11日
首先提交符合 QC 标准的
2013年12月16日
首次发布 (估计)
2013年12月23日
研究记录更新
最后更新发布 (实际的)
2017年10月9日
上次提交的符合 QC 标准的更新
2017年10月6日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FORE-SIGHT
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