Emergency Front of the NecK Access (eFONA) in Children
Condition: Pediatric Anesthesia; Intubation;Difficult
MeSH terms: Emergencies
Study type: Interventional

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).
    

Detailed description: 
      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.
    

Intervention name(s): a rapid sequence tracheostomy (RST) on rabbit cadaver
Intervention type(s): Other
Intervention description(s): The Rapid Sequence Tracheostomy (RST) consists of the following steps:
Orientational palpation and vertical midline skin incision followed by separation of the strap muscles
Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp
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.
An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 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).
Masking: None (Open Label)
Primary purpose: Other