Pediatric Neck Rescue Access Comparison

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tracheostomy Complication, Anesthesia

Intervention / Treatment
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* Procedure: scalpel-bougie tracheostomy
* Procedure: rapid sequence tracheotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: board certified pediatric anesthesiologists or pediatric intensive care doctor informed consent signed Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric airway, tracheotomy, eFONA, CICO