NCT05499273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

June 24, 2022

Last Update Submit

March 7, 2023

Conditions

Tracheostomy ComplicationAnesthesia

Keywords

pediatric airwaytracheotomyeFONACICO

Outcome Measures

Primary Outcomes (1)

  • Performance Time

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

    2 min

Secondary Outcomes (4)

  • rate of cricoid injuries

    2 min

  • Succes rate

    2 min

  • rate of thyroid injuries

    2 min

  • number of tracheal ring damaged

    2 min

Study Arms (2)

scalpel-bougie tracheostomy (SBT)

ACTIVE COMPARATOR

SBT technique described in Interventions

Procedure: scalpel-bougie tracheostomyProcedure: rapid sequence tracheotomy

rapid sequence tracheotomy (RST

ACTIVE COMPARATOR

RST technique described in Interventions

Procedure: scalpel-bougie tracheostomyProcedure: rapid sequence tracheotomy

Interventions

scalpel-bougie tracheostomyPROCEDURE

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.

Also known as: SBT
rapid sequence tracheotomy (RSTscalpel-bougie tracheostomy (SBT)
rapid sequence tracheotomyPROCEDURE

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.

Also known as: RST
rapid sequence tracheotomy (RSTscalpel-bougie tracheostomy (SBT)

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37950428DERIVED

Study Officials

  • Thomas Riva, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

June 24, 2022

First Posted

August 12, 2022

Study Start

May 25, 2022

Primary Completion

March 3, 2023

Study Completion

March 8, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

CH(1)