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临床试验/NCT03057587
NCT03057587撤回不适用

The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology

Boston Children's Hospital1 个研究点 分布在 1 个国家开始时间: 2017年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Cerebral Oxygenation

研究概览

简要总结

This study will be an observational, prospective trial that will measure the cerebral oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.

详细描述

Data will be collected from the Near Infrared Spectroscopy (NIRS) monitor and the patient's medical record. When the NIRS sensor is attached to the patient's forehead the oxygenation of brain tissue will be continuously monitored. All other information will be routinely recorded as standard clinical care and this information will be obtained from the patient's medical record. The NIRS monitor data will by time synched to the anesthesia record and downloaded to a secured password protected file.

In the post-operative period, patient data will be collected including: 1) any skin findings related to the placement of the NIRS or pulse oximetry probes 2) any unanticipated need for hemodynamic support, 3) laboratory values including hemoglobin levels, electrolytes, and blood gases, 4) new neurological findings (seizures etc.)

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
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children less than 6 months of age
  • Undergoing a scheduled or emergent procedure with anesthesia at Boston Children's Hospital

排除标准

  • Placement of NIRS sensor that will interfere with surgery
  • Child has an allergy to medical grade adhesives or pre-existing skin irritation at the sensor site
  • Scheduled for a cardiac procedure
  • Patient's care team or patient's family declines participation
  • American Society of Anesthesiologists (ASA) criteria of IV or greater
  • Infants who are being treated with sympathomimetic medications intraoperatively

结局指标

主要结局

Cerebral Oxygenation

时间窗: Intraoperative period

Determine what factors are correlated with changes in the cerebral oxygenation

次要结局

未报告次要终点

研究者

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

Mary Ellen McCann

MD, MPH

Boston Children's Hospital

研究点 (1)

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