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Neck Rescue Access Comparison
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
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.
Official title: Emergency Front-of-neck Access in Infants: A Crossover Trial Evaluating Surgical and Percutaneous eFONA Techniques in a Simulated Rabbit Model
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-02-02
Completion Date
2026-12
Last Updated
2026-02-06
Healthy Volunteers
Yes
Interventions
Percutaneous Seldinger-Guided Tracheal Access (Melker)
1. The operator palpates and stabilizes the trachea in the midline. A syringe is attached to the introducer needle. 2. The needle is advanced through the skin in the midline with continuous aspiration until intratracheal placement is confirmed by free air aspiration. 3. A flexible guidewire is inserted through the needle into the tracheal lumen. 4. The needle is removed while maintaining the guidewire in position. 5. A dilator with integrated airway catheter is advanced over the guidewire using controlled rotational pressure. 6. After intratracheal placement, the dilator and guidewire are removed. 7. The cuffed airway catheter (inner diameter 3.5 mm) is connected to a ventilation device to establish ventilation.
scalpel-bougie tracheostomy
1\. The assistant places themselves with two preparation clamps at the head end of the table and assists with each hand placed lateral to the neck, so that the operating field is freely accessible. After the trachea or cricoid is palpated, a long median longitudinal skin incision of 2-3 cm is made from the cricoid caudally 2. The assistant uses straight clamps to pull the two edges of the skin incision apart dorso-laterally. In the event of major bleeding this maneuver should allow the blood to drain off dorsally and the view of the anatomical structures should be less impaired. 3. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly. 4. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid 5. An 8 FR Frova catheter is inserted through the orifice into trachea. 6. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.
Locations (1)
Universitätsspital Bern
Bern, Switzerland