Pediatric Neck Rescue Access Comparison

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05499273
• Other study ID #: Riva-Ulmer2022
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 8, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• board certified pediatric anesthesiologists or pediatric intensive care doctor

• informed consent signed

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Anesthesia
• Tracheostomy Complication

Intervention

Procedure:
• scalpel-bougie tracheostomy
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 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. Layer by layer of the anatomical structures are cut through with the scalpel and tightened with the clamps accordingly. Using a longitudinal incision, two to three tracheal rings are cut through distally to the cricoid An 8 FR Frova catheter is inserted through the orifice into trachea. A tracheal tube (ID 3.0 mm) is inserted over the Frova catheter to secure the airway permanently.
• rapid sequence tracheotomy
Orientational palpation and vertical midline skin incision followed by separation of the strap muscles Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp 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. A tracheal tube (inner diameter 3.0 mm, cuffed) is inserted to secure the airway permanently.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Gaslini Children's Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Time	performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.	2 min
Secondary	rate of cricoid injuries	rate of cricoid cartilage injuries during procedure, that would preclude ventilation measured in %	2 min
Secondary	Succes rate	succes rate in %	2 min
Secondary	rate of thyroid injuries	rate of thyroid cartilage injuries during the procedure that would preclude ventilation, measured in %	2 min
Secondary	number of tracheal ring damaged	number of damaged tracheal rings and perforation of the posterior tracheal wall during procedure	2 min