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Completed

NCT Number: NCT05499273

Pediatric Neck Rescue Access Comparison

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.

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Key information

Conditions

Tracheostomy Complication Anesthesia

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

scalpel-bougie tracheostomy

Procedure
  • 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

rapid sequence tracheotomy

Procedure
  • 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

Primary outcomes

  1. Performance Time

    Time frame: 2 min

    performance time between the rapid sequence tracheotomy technique and the scalpel-bougie tracheostomy technique.

Secondary outcomes

  1. rate of cricoid injuries

    Time frame: 2 min

    rate of cricoid cartilage injuries during procedure, that would preclude ventilation measured in %

  2. Succes rate

    Time frame: 2 min

    succes rate in %

  3. rate of thyroid injuries

    Time frame: 2 min

    rate of thyroid cartilage injuries during the procedure that would preclude ventilation, measured in %

  4. number of tracheal ring damaged

    Time frame: 2 min

    number of damaged tracheal rings and perforation of the posterior tracheal wall during procedure

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Gaslini Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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