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Pediatric Neck Rescue Access Comparison

I

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Tracheostomy Complication
Anesthesia

Treatments

Procedure: scalpel-bougie tracheostomy
Procedure: rapid sequence tracheotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05499273
Riva-Ulmer2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • none

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

scalpel-bougie tracheostomy (SBT)
Active Comparator group
Description:
SBT technique described in Interventions
Treatment:
Procedure: scalpel-bougie tracheostomy
Procedure: rapid sequence tracheotomy
rapid sequence tracheotomy (RST
Active Comparator group
Description:
RST technique described in Interventions
Treatment:
Procedure: scalpel-bougie tracheostomy
Procedure: rapid sequence tracheotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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