The Safety and Efficacy of Supraglottic Airway Use in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Supraglottic Airway Device Failure
研究概览
简要总结
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.
详细描述
This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.
Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation
排除标准
- 未提供
结局指标
主要结局
Supraglottic Airway Device Failure
时间窗: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
次要结局
- Intraoperative Complications(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Postoperative Complications(participants will be followed for the duration of anesthesia and 24 hours postoperatively)
- Airway Maneuvers/interventions(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Occurrence of Inadequate Ventilation(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Multiple Attempts to Place Supraglottic Airway Device(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease of Placement of Supraglottic Airway Device(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
研究者
Narasimhan Jagannathan
Primary Investigator; MD
Ann & Robert H Lurie Children's Hospital of Chicago