The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology
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
- 否
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
Mary Ellen McCann
MD, MPH
Boston Children's Hospital
