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Emergency Front of the NecK Access (eFONA) in Children

NCT03576352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-01-11

No results posted yet for this study

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. 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).

Conditions

  • Pediatric Anesthesia
  • Intubation;Difficult

Interventions

OTHER

a rapid sequence tracheostomy (RST) on rabbit cadaver

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Greif Robert, Prof. · Department Anesthesia and Pain Therapy, University Hospital Bern

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-11-10
Completion
2018-12-23

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576352 on ClinicalTrials.gov