Pediatric Neck Rescue Access Comparison

Not Applicable

Completed

• Conditions: Anesthesia; Tracheostomy Complication
• Interventions: Procedure: scalpel-bougie tracheostomy; Procedure: rapid sequence tracheotomy

• Registration Number: NCT05499273
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Status Verified: 2023-03
• Primary Completion: 2023-03-03
• Last Update Submitted: 2023-03-07
• Study Completion: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rapid sequence tracheotomy (RST	scalpel-bougie tracheostomy	RST technique described in Interventions
rapid sequence tracheotomy (RST	rapid sequence tracheotomy	RST technique described in Interventions
scalpel-bougie tracheostomy (SBT)	scalpel-bougie tracheostomy	SBT technique described in Interventions
scalpel-bougie tracheostomy (SBT)	rapid sequence tracheotomy	SBT technique described in Interventions

Primary Outcome Measures

Name	Time	Method
Performance Time	2 min	performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.

Secondary Outcome Measures

Name	Time	Method
rate of thyroid injuries	2 min	rate of thyroid cartilage injuries during the procedure that would preclude ventilation, measured in %
rate of cricoid injuries	2 min	rate of cricoid cartilage injuries during procedure, that would preclude ventilation measured in %
Succes rate	2 min	succes rate in %
number of tracheal ring damaged	2 min	number of damaged tracheal rings and perforation of the posterior tracheal wall during procedure

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland