NCT05499273

Pediatric Neck Rescue Access Comparison

Pediatric Neck Rescue: Randomized Comparison of Two Emergency Approaches to the Trachea in an Advanced Simulated Rabbit Model

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

Summary

Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.

Detailed description

With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.

Conditions

• Tracheostomy Complication
• Anesthesia

Interventions

Type	Name	Description
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.
PROCEDURE	rapid sequence tracheotomy	1. Orientational palpation and vertical midline skin incision followed by separation of the strap muscles 2. Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp 3. Perform a vertical puncture with a tip scissors between the cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length. 4. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-03-03
• Completion: 2023-03-08
• First posted: 2022-08-12
• Last updated: 2023-03-09

Locations

1 site across 1 country: Switzerland