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临床试验/NCT00166101
NCT00166101已完成不适用

Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion

Emory University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2002年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1

研究概览

简要总结

Due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery. This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the traditional methods of determining oxygen saturation.

详细描述

One of the limiting factors in treating infants undergoing cardiac surgery is the difficulty in assessing systemic perfusion with accuracy. At Children's Healthcare of Atlanta, Near-infrared Spectroscopy (NIRS) is available, but has never been studied. In patients undergoing first stage palliation (Norwood) for hypoplastic left heart, routine management will be utilized in addition to the NIRS monitor. The following will be documented pre- and post-bypass, then every 4 hours for 24 hours after admission to the Cardiac Intensive Care Unit:NIRS readings, Lactic acid levels,mixed venous saturations,hemoglobin, hematocrit, arterial blood gases, heart rate, blood pressure, central venous pressure, left atrium pressure,core temperature, toe temperature, pulse oximeter reading, urine output, ventilator settings, inotropic levels. All the data will be entered into a database and analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • hypoplastic left heart
  • requiring stage 1 palliation
  • informed consent obtained

排除标准

  • does not have hypoplastic left heart
  • is not having stage 1 palliation
  • no informed consent

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven R Tosone MD

Assistant Professor

Emory University

研究点 (1)

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