NCT07368179

Neck Rescue Access Comparison

Emergency Front-of-neck Access in Infants: A Crossover Trial Evaluating Surgical and Percutaneous eFONA Techniques in a Simulated Rabbit Model

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Tracheostomy Complication
• Emergency Front of Neck Airway in Children
• Anesthesia

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2026-01-26
• Last updated: 2026-02-06

Locations

1 site across 1 country: Switzerland