Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation (PEDSGAP): A Multicentric Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,750
- 试验地点
- 6
- 主要终点
- The incidence of difficulty in supraglottic airway device(SGA) placement
研究概览
简要总结
This study is designed to observe the occurrence of failure or difficulty during placement of supraglottic airway devices (SGAs) and its associated risk factors in pediatric patients. Despite wide use in pediatric practice, not much is known related to problems during SGA insertion unlike adults. The main information regarding pediatric SGA comes from either small comparative studies or retrospective studies reporting increased risk of failure. Thus the main aim of this prospective, multicentric, observational study is to determine the incidence of "difficult" or "failed" SGA placement in children and clarify the possible risk factors for difficulty.
详细描述
Inclusion criteria
- 1- 12 years old peditatric patients
- ASA class I- III
- Scheduled for elective surgery under general anaesthesia, in whom a SGA would be used for airway maintenance
- Planned surgery under general anesthesia with SGA
- Patients whose legal guardians provide informed consent
Exclusion criteria
- Refusal to participate in the study.
- Inability of patient or parents to understand the study or consent process
- Orotracheal intubation requirement
- Pathology of airway, neck, respiratory tract, upper gastrointestinal tract
- Increased risk of regurgitation or aspiration
- Emergency surgeries
- Requirement for intensive care follow-up after the surgery
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 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- 12 years old peditatric patients
- •ASA class I- III
- •Planned surgery under general anesthesia with supraglottic airway
- •Patients whose legal guardians provide informed consent
排除标准
- •Refusal to participate in the study
- •Inability of patient or parents to understand the study or consent process
- •Orotracheal intubation requirement
- •Pathology of airway, neck, respiratory tract, upper gastrointestinal tract
- •Increased risk of regurgitation or aspiration
- •Emergency surgeries
- •Requirement for intensive care follow-up after the surgery
结局指标
主要结局
The incidence of difficulty in supraglottic airway device(SGA) placement
时间窗: Immediately after the attempt of insertion and up to the end of the surgery
Difficulty in placing SGA is defined as follows: SGA insertion that requires more than one attempt,need for a change the size or type of SGA,desatutaion (SpO2\<93%), disrupted capnography,high airway pressure (\>25 cmH2O of peak pressure)
次要结局
- The incidence of complications related to SGA insertion(Up to 24 hours after surgery)
- Risk factors for pediatric difficult SGA placement(At the beginning of anesthesia)
研究者
Alper Kilicaslan
Prof
Konya Necmettin Erbakan Üniversitesi