An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 687
- 试验地点
- 15
- 主要终点
- Incidence of isoelectric EEG events in young children.
研究概览
简要总结
Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.
详细描述
Study will consist of placing a forehead EEG on the subject prior to induction of general anesthesia. EEG recording will continue until the end of anesthesia care. The anesthesiologist will be blinded to the EEG results during the study. Peri-operative factors such as demographics, vital signs, medications, etc... will also be recoded. Each site is expected to enroll up to 75 patients to provide at least 50 evaluable subjects. EEG files will be reviewed after recordings.
After informed consent has been obtained, the subject will receive standard anesthetic care as administered by the anesthesia provider, who will be blinded to the EEG display and data. EEG recording will continue until the end of anesthesia care.
After the recording, the EEG file will be reviewed and the number and duration of isoelectric events will be analyzed. Additional data that will be recorded include: patient demographic and perioperative factors (surgical procedure, anesthetic medications, end tidal anesthetic levels, induction and recovery room behavior, physiologic data, and time-stamps for intraoperative event. Post-operative questionnaire may also be sent to parents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 0 to 36 (inclusive) months
- •Greater than 36 weeks post-menstrual age (PMA) on the day of study
- •Undergo general anesthesia for surgery that is expected to last more than 30 minutes (combined anesthesia and surgical time).
- •Anesthetic maintenance with Sevoflurane if using volatile anesthetic or Propofol infusion if using total intravenous anesthetic.
- •Expected airway management with a Laryngeal Mask Airway (LMA) or tracheal tube.
- •Parental/legal guardian permission (informed consent) obtained
排除标准
- •American Society of Anesthesiology (ASA) (physical status) greater than 3
- •Structural/anatomical frontal brain malformations or other circumstances that make it difficult to apply the sensor to the forehead.
- •History of abnormal EEG or severe neurological abnormalities.
- •Scheduled for surgery above the neck, cardiac, brain, or emergency surgery.
- •Known allergy or adverse reaction to ECG adhesives.
- •On a sedative infusion (eg, propofol, morphine, fentanyl, midazolam, dexmedetomidine, ketamine) or recently on a sedative infusion (discontinued <24 hours ago)
- •Received ketamine within 8 hours prior to the induction of general anesthesia
结局指标
主要结局
Incidence of isoelectric EEG events in young children.
时间窗: Up to 6 months after EEG recording
Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels.
次要结局
- Association of isoelectric EEG events between gender groups(Up to 12 months after EEG recording)
- Patient Weight associated with isoelectric EEG events(Up to 12 months after EEG recording)
- Changes in patient's physical status associated with isoelectric EEG events(Up to 12 months after EEG recording)
- Procedure length associated with isoelectric EEG events(Up to 12 months after EEG recording.)
- Heart rate associated with isoelectric EEG events(Up to 12 months after EEG recording.)
- Discontinuity of isoelectric EEG events among age groups(Up to 12 months after EEG recording.)
- Patient Gestational Age associated with isoelectric EEG events(Up to 12 months after EEG recording)
- Incidence of anesthetic type(Up to 12 months after EEG recording.)
- Anesthesia dose(Up to 12 months after EEG recording.)
- Blood pressure associated with isoelectric EEG events(Up to 12 months after EEG recording.)
- Anesthesia Recovery time associated with isoelectric EEG events.(Up to 12 months after EEG recording.)
- End tidal carbon dioxide (CO2) associated with isoelectric EEG events.(Up to 12 months after EEG recording.)
- Changes in quality of life(Up to 2 months after EEG recording)