Clinical Trial

Neck Rescue Access Comparison

Study acronym: eFONA

Enrolling by Invitation

Record status

This record was last updated February 6, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2026-01-20.

Trial Details

NCT Number	NCT07368179
Lead Sponsor	Insel Gruppe AG, University Hospital Bern Collaborators: Gaslini Children's Hospital
Conditions	Tracheostomy Complication, Emergency Front of Neck Airway in Children, Anesthesia
Enrollment	30 participants
Start Date	2026-02-02
Primary Completion	2026-06 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-06