Emergency Front of the NecK Access (eFONA) in Children

NCT03576352 | Completed DMC

• 1 other identifier: Riva-Ulmer2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Orientational palpation and vertical midline skin incision followed by separation of the strap muscles
2. 2.Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp
3. 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. 4.An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated.

Conditions

Pediatric Anesthesia; Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• Performance time

  The primary outcome will be performance time of RST representing the time from touching the skin until ventilation of the trachea (visualized by lung expansion) indicating the artificial airway as established. Performance time will yield learning curves. The declared intention is to perform RST in less than 60 seconds. Failed/aborted RST will be registered as a 5-minute attempt

  60 seconds

Secondary Outcomes (6)

• Number of attempts

  1 hour

• Number of attempts for plateau

  1 hour

• Preparation of the trachea

  60 seconds

• Vertical incision

  60 seconds

• Training

  1 hour

Study Arms (4)

Pediatric anesthesiologist

EXPERIMENTAL

10 rapid sequence tracheostomy (RST) on rabbit cadaver

Other: a rapid sequence tracheostomy (RST) on rabbit cadaver

Pediatric intensivists

EXPERIMENTAL

10 rapid sequence tracheostomy (RST) on rabbit cadaver

Other: a rapid sequence tracheostomy (RST) on rabbit cadaver

Pediatric surgeons

EXPERIMENTAL

10 rapid sequence tracheostomy (RST) on rabbit cadaver

Other: a rapid sequence tracheostomy (RST) on rabbit cadaver

Pediatric emergency physicians

EXPERIMENTAL

10 rapid sequence tracheostomy (RST) on rabbit cadaver

Other: a rapid sequence tracheostomy (RST) on rabbit cadaver

Interventions

a rapid sequence tracheostomy (RST) on rabbit cadaver OTHER

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.

Pediatric anesthesiologist; Pediatric emergency physicians; Pediatric intensivists; Pediatric surgeons

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• none

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• Ulmer F, Lennertz J, Greif R, Butikofer L, Theiler L, Riva T. Emergency front of neck access in children: a new learning approach in a rabbit model. Br J Anaesth. 2020 Jul;125(1):e61-e68. doi: 10.1016/j.bja.2019.11.002. Epub 2019 Dec 4.

  PMID: 31812268 DERIVED

Study Officials

• Greif Robert, Prof.

  Department Anesthesia and Pain Therapy, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anesthesiologist, pediatric intensivists, surgeons, and emergency physicians who are most likely to need to perform FONA in small children, shall learn to perform RST emergent pediatric tracheotomy in less than 60 seconds. The investigators seek to measure and study their learning curves for establishing an artificial airway using the RST. Single-center interventional trial. The only inclusion criterion is informed consent. A high quality instructional video demonstrating the RST on a rabbit cadaver will teach the participants. Performance time will be defined (from touching the skin until ventilation of the trachea with a standard self-inflating bag connected to the tube).

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 3, 2018
• Study Start: May 1, 2018
• Primary Completion: November 10, 2018
• Study Completion: December 23, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CH (1)