NCT03128931终止不适用
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of Participants For Whom the EEG Data Collection Was Completed
研究概览
简要总结
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 17 years old and younger
- •ASA status I, II, or III.
- •Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).
排除标准
- •Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit.
- •Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions).
- •Subjects who are developmentally delayed.
- •Subjects deemed not suitable for study at the discretion of the investigator.
结局指标
主要结局
Number of Participants For Whom the EEG Data Collection Was Completed
时间窗: Duration of surgery
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
次要结局
未报告次要终点
研究者
研究点 (2)
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