Neck Rescue Access Comparison

NCT07368179 | Enrolling By Invitation DMC

• 1 other identifier: FONA Riva2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

pediatric airway; tracheotomy; eFONA; CICO

Outcome Measures

Primary Outcomes (1)

• Performance Time

  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.

  During the procedure; measured from initial palpation of the trachea until establishment of a secured airway with confirmed lung ventilation

Secondary Outcomes (4)

• 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)

Study Arms (2)

Percutaneous Seldinger-Guided Tracheal Access (Melker)

ACTIVE COMPARATOR

Melker technique described in Interventions

Procedure: Percutaneous Seldinger-Guided Tracheal Access (Melker)

scalpel-bougie tracheostomy (SBT)

ACTIVE COMPARATOR

SBT Technique described in Interventions

Procedure: scalpel-bougie tracheostomy

Interventions

Percutaneous Seldinger-Guided Tracheal Access (Melker) PROCEDURE

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.

Also known as: Melker

Percutaneous Seldinger-Guided Tracheal Access (Melker)

scalpel-bougie tracheostomy PROCEDURE

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.

Also known as: SBT

scalpel-bougie tracheostomy (SBT)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• board certified pediatric anesthesiologists or pediatric intensive care doctor
• informed consent signed

You may not qualify if:

• none

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Gaslini Children's Hospital: collaborator

Study Sites (1)

Universitätsspital Bern

Bern, 3010, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)