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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05499273
Enrollment
30
Registered
2022-08-12
Start date
2022-05-25
Completion date
2023-03-08
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Tracheostomy Complication

Keywords

pediatric airway, tracheotomy, eFONA, CICO

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.

Interventions

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.

PROCEDURErapid 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.

Sponsors

Gaslini Children's Hospital
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Performance Time2 minperformance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.

Secondary

MeasureTime frameDescription
rate of cricoid injuries2 minrate of cricoid cartilage injuries during procedure, that would preclude ventilation measured in %
Succes rate2 minsucces rate in %
rate of thyroid injuries2 minrate of thyroid cartilage injuries during the procedure that would preclude ventilation, measured in %
number of tracheal ring damaged2 minnumber of damaged tracheal rings and perforation of the posterior tracheal wall during procedure

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026