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| Name | Class |
|---|---|
| Gaslini Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scalpel-bougie tracheostomy (SBT) | Active Comparator | SBT technique described in Interventions |
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| rapid sequence tracheotomy (RST | Active Comparator | RST technique described in Interventions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scalpel-bougie tracheostomy | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance Time | performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique. | 2 min |
| 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 % |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Riva, MD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37950428 | Derived | Riva T, Goerge S, Fuchs A, Greif R, Huber M, Lusardi AC, Riedel T, Ulmer FF, Disma N. Emergency front-of-neck access in infants: A pragmatic crossover randomized control trial comparing two approaches on a simulated rabbit model. Paediatr Anaesth. 2024 Mar;34(3):225-234. doi: 10.1111/pan.14796. Epub 2023 Nov 10. |
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| rapid sequence tracheotomy | Procedure |
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| 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 |