Pediatric Neck Rescue Access Comparison

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Tracheostomy Complication
• Intervention / Treatment: Procedure: scalpel-bougie tracheostomy; Procedure: rapid sequence tracheotomy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: scalpel-bougie tracheostomy (SBT); SBT technique described in Interventions	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.; Other Names: SBT; Procedure: 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.; Other Names: RST
Active Comparator: rapid sequence tracheotomy (RST; RST technique described in Interventions	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.; Other Names: SBT; Procedure: 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.; Other Names: RST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Time	performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.	2 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Gaslini Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: tracheotomy; pediatric airway; eFONA; CICO
• Other Study ID Numbers: Riva-Ulmer2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No