Intubation;Difficult Clinical Trial
— eFONAOfficial title:
Pediatric Emergency Front of the Neck Access (eFONA): Assessing a Novel Experiential Learning Approach
Verified date | January 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | December 23, 2018 |
Est. primary completion date | November 10, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: Inclusion criteria are informed consent, no previous experience in FONA. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of attempts | Number of attempts to perform the skill in <60 s | 1 hour | |
Secondary | Number of attempts for plateau | Number of attempts to reach a time plateau | 1 hour | |
Secondary | Preparation of the trachea | Time to vertical incision of the trachea with the sharp tip scissors | 60 seconds | |
Secondary | Vertical incision | Time to vertical incision of the trachea with the sharp tip scissors | 60 seconds | |
Secondary | Training | Number of times that training video was watched | 1 hour | |
Secondary | Suitability | The subjective rating of the suitability of the given training model | 1 hour |
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