Intubation;Difficult Clinical Trial
Official title:
Pediatric Emergency Front of the Neck Access (eFONA): Assessing a Novel Experiential Learning Approach
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).
Current difficult airway algorithms end with the need for tracheal airway access to be
obtained via Front Of Neck Access (FONA) to achieve oxygenation. In children < 8 years
existing recommendations and the literature do not offer guidance on how to perform emergent
FONA. Emergent tracheotomy is the potentially life-saving procedure - which needs to be
performed without delay. When emergent tracheotomy is attempted in children < 8 years of age,
there is a substantial risk for complications. As a result, health care providers who do not
have routine at performing this procedure are often reluctant to perform FONA, Diameters,
vertical/horizontal dimensions, vocal cord distance, larynx position, and cricothyroid
membrane size of the rabbit airway suggest considerable similarities with infant airways,
making it a good model to learn this technique. The FONA rapid sequence technique (RST) is a
simple technique suitable for emergent pediatric tracheotomy. RST outlines 4 clearly defined
steps, that enable airway establishment.
Step 1: Vertical midline skin incision and separate the strap muscles Step 2: Expose trachea
and cricoid through palpation, lift and immobilize trachea with a clamp Step 3: Vertical
trachea incision with the sharp tip scissors (2 cm) Step 4: Open the trachea and insert the
tube The steps are easy to perform, if sufficiently practiced. 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 learning curves of participants for
establishing an artificial airway using the RST.
Hypothesis: After having practiced the procedure 10 times, 80% of study participants will not
be able to successfully demonstrate FONA within 60 seconds. Alternative hypothesis: study
participants will be able to successfully demonstrate FONA within 60 seconds.
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). The investigators seek
to assess the learning curves of participants.
Sample size. In order to obtain a lower limit of the 95% Confidence interval of 80% success
in FONA the investigators would need 40 study participants assuming 2 failures by the 10th
attempt. Statistical methods: Descriptive statistics for demographics. To establish the
learning curve the increase over the 3 attempts will be analyzed by repeated ANOVA or
Friedman.
For the reasons outlined above the investigators will provide a suitable and valid training
model for pediatric airway practitioners to practice the invasive front of neck access
technique.
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