NCT03576352: eFONA

Emergency Front of the NecK Access (eFONA) in Children

Completed NA Last updated 11 January 2019

What this trial tests

NA trial testing a rapid sequence tracheostomy (RST) on rabbit cadaver in Pediatric Anesthesia in 50 participants. Completed in 23 December 2018.

Timeline

1 May 2018

Primary endpoint
10 November 2018

23 December 2018

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	50
Start date	1 May 2018
Primary completion	10 November 2018
Estimated completion	23 December 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• a rapid sequence tracheostomy (RST) on rabbit cadaver

Conditions studied

• Pediatric Anesthesia — all drugs for Pediatric Anesthesia →
• Intubation;Difficult — all drugs for Intubation;Difficult →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 25 to 65, any sex, with Pediatric Anesthesia or Intubation;Difficult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study participants will be shown an illustrated training video demonstrating and explaining the RST. The video may be reviewed until the participant feels confident to perform procedure.

The Rapid Sequence Tracheostomy (RST) consists of the following steps:

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. An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated.

Teaching methodology: Prior to the hands-on training of eFONA, all participants shall watch a 2-minute training video of RST performed on rabbit cadaver following the steps outlined above. During video demonstration, no additional explanation or support will be provided.

Once study participants express confidence to perform the skill, participants shall attempt to perform the RST 10 times. During the RST procedure no additional explanation or support will be provided. Study participants will be allowed to watch the video again between attempts, if needed. Each attempt will be video recorded and time recorded for rater analysis, as outlined above. Successful tracheotomy is defined as ventilation of the lungs by way of a standard self-inflating bag that is to be connected to the tracheal tube or visual confirmation of the tube being placed at least 2 cm inside the trachea (dissection of the rabbit cadaver performed by assistant).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emergency front of neck access in children: a new learning approach in a rabbit model.
   Ulmer F, Lennertz J, Greif R, Bütikofer L, et al · · 2020 · cited 19× · PMID 31812268 · DOI 10.1016/j.bja.2019.11.002