Emergency Front-of-neck Access in Infants: A Crossover Trial Evaluating Surgical and Percutaneous eFONA Techniques in a Simulated Rabbit Model
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Performance Time
研究概览
简要总结
Emergency front-of-neck access (eFONA) represents the final lifesaving intervention in a pediatric "can't intubate, can't oxygenate" scenario. Despite its importance, there is no consensus on the optimal eFONA technique in infants, and existing evidence is limited by low-fidelity models and a lack of randomized crossover comparisons. The objective of this randomized crossover simulation trial is to compare a surgical scalpel-bougie tracheostomy technique with a percutaneous Seldinger-guided technique under standardized, high-fidelity simulated infant emergency conditions. Using a rabbit cadaver model with simulated bleeding, physiological deterioration, and anatomical constraints, the study aims to assess time to successful ventilation and procedure-related injury patterns for both techniques.
详细描述
With approval from the competent ethics committee, this single-center randomized crossover simulation trial will recruit board-certified pediatric anesthesiologists and pediatric intensivists. Participants will be randomized to perform either a percutaneous Seldinger-guided front-of-neck access technique or a surgical scalpel-bougie tracheostomy technique first, followed by crossover to the alternative technique.
Prior to assessment, participants will receive standardized video-based instruction for the assigned technique and will complete four supervised practice attempts on rabbit cadavers. A fifth attempt will be formally assessed. The same process will then be repeated after crossover to the second technique. Participants will be allowed to re-watch the instructional videos throughout the study.
All procedures will be performed on prepared rabbit cadavers in a high-fidelity simulated infant emergency environment. Anatomical realism will be enhanced using an infant mannequin head, shoulder roll, and standardized positioning. Psychological stress will be simulated using an audible oxygen saturation monitor with progressive desaturation and bradycardia. Physiological realism will be further enhanced by continuous simulated bleeding during the procedure using an infusion system delivering artificial blood near the trachea.
Performance time will be measured from skin contact to confirmed ventilation, defined by visible lung expansion. A procedure duration exceeding three minutes will be classified as failure. Procedure-related injuries, including damage to tracheal structures and posterior wall perforation, will be systematically documented. Each participant acts as their own control, minimizing inter-individual variability.
The study is designed to provide comparative data on performance efficiency and safety profiles of two fundamentally different pediatric eFONA techniques under realistic emergency conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •board certified pediatric anesthesiologists or pediatric intensive care doctor
- •informed consent signed
排除标准
- 未提供
研究组 & 干预措施
Percutaneous Seldinger-Guided Tracheal Access (Melker)
Melker technique described in Interventions
干预措施: Percutaneous Seldinger-Guided Tracheal Access (Melker) (Procedure)
scalpel-bougie tracheostomy (SBT)
SBT Technique described in Interventions
干预措施: scalpel-bougie tracheostomy (Procedure)
结局指标
主要结局
Performance Time
时间窗: During the procedure; measured from initial palpation of the trachea until establishment of a secured airway with confirmed lung ventilation
Performance time between the percutaneous Seldinger-guided tracheal access and the scalpel-bougie tracheostomy technique. If tracheal access was not achieved within two minutes, the attempt was terminated and recorded as unsuccessful.
次要结局
- Success rate of emergency front-of-neck airway establishment(During the procedure)
- rate of thyroid cartilage injuries(Immediately after the procedure (post-procedural inspection))
- rate of cricoid injuries(Immediately after the procedure (post-procedural inspection))
- number of tracheal ring damaged(Immediately after the procedure (post-procedural inspection))