Evaluation of the ScalpelCric Set and Comparison With Two Further Techniques of Cricothyrotomy

Study Overview
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Brief Summary
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During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique. Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.

Detailed Description
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The investigators plan to recruit medical students (University Mainz), paramedics (employed in ambulance and rescue helicopter), trainee anaesthetists and consultants of the department of anesthesiology from the university hospital Mainz. After written informed consent the participants have to complete an pre-study questionnaire, than the participants get an information sheet about the 3 techniques and the investigators show the participants a short video demonstrating the different techniques. All participants have the opportunity to practice one insertion with each method on a plastic laryngeal model. After that the participants have to perform each technique on the plastic model and the investigators measure the time from initially handling equipment to the final end-point, which the investigators take as a successful placement of the endotracheal tube verified by a fiberoptic position check.

Official Title
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Evaluation of the Novel ScalpelCric Set for Cricothyrotomy Corresponding the Scalpel-Bougie Technique and Comparison With Two Further Techniques of Cricothyrotomy on a Plastic Laryngeal Model (A) and Comparison of the Novel ScalpelCric Set With Surgical Cricothyrotomy in a Porcine Laryngeal Model (B) Influence of Training (A+B) in a Simulation

Conditions
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Cricothyroidotomy

Intervention / Treatment
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* Device: Scalpel Bougie technique (plastic laryngeal model)
* Device: Seldinger technique (plastic laryngeal model)
* Device: Surgical technique (plastic laryngeal model)
* Device: Scalpel Bougie technique (porcine laryngeal model)
* Device: Surgical technique (porcine laryngeal model)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent German language in speaking and writing Capability of giving consent Exclusion Criteria: Participants unwilling or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consultants<br> | Device: Scalpel Bougie technique (plastic laryngeal model)<br>* ScalpelBougie Set<br>Device: Seldinger technique (plastic laryngeal model)<br>* Melker Set<br>Device: Surgical technique (plastic laryngeal model)<br>* Scalpel and speculum<br>Device: Scalpel Bougie technique (porcine laryngeal model)<br>* ScalpelCric Set<br>Device: Surgical technique (porcine laryngeal model)<br>* Scalpel and speculum<br>|
| Trainee anaesthetists<br> | Device: Scalpel Bougie technique (plastic laryngeal model)<br>* ScalpelBougie Set<br>Device: Seldinger technique (plastic laryngeal model)<br>* Melker Set<br>Device: Surgical technique (plastic laryngeal model)<br>* Scalpel and speculum<br>Device: Scalpel Bougie technique (porcine laryngeal model)<br>* ScalpelCric Set<br>Device: Surgical technique (porcine laryngeal model)<br>* Scalpel and speculum<br>|
| Paramedics<br> | Device: Scalpel Bougie technique (plastic laryngeal model)<br>* ScalpelBougie Set<br>Device: Seldinger technique (plastic laryngeal model)<br>* Melker Set<br>Device: Surgical technique (plastic laryngeal model)<br>* Scalpel and speculum<br>|
| Students<br> | Device: Scalpel Bougie technique (plastic laryngeal model)<br>* ScalpelBougie Set<br>Device: Seldinger technique (plastic laryngeal model)<br>* Melker Set<br>Device: Surgical technique (plastic laryngeal model)<br>* Scalpel and speculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check |  | up to 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in the first trial |  | up to 3 minutes | 
| Number of trials |  | up to 3 minutes | 
| Dimension of the tracheal trauma | horizontally and vertically in mm | up to 10 minutes | 
| Comfort evaluation by the performer | Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult | up to 15 minutes | 
| Influence of training on the time to decision making for cricothyrotomy | After performing the different techniques of cricothyrotomy on a platistic and a porcine laryngeal model, the participants will complete a simulator training for a cannot intubate and cannot ventilate scenario. Time to decide (measured in seconds) to perform cricothyrotomy will be measured from the beginning of the scenario. | up to 5 hours | 
| Influence of training on choosing the technique | After performing the different techniques of cricothyrotomy on a platistic and a porcine laryngeal model, the participants will complete a simulator training for a cannot intubate and cannot ventilate scenario. The technique (Scalpel bougie, seldinger, surgical) of cricotyrotomy, chosen by the participant will be reported and compared with the preferred technique, the participant had chosen before performing the training. | up to 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVCI, Emergency medicine, Airway management, Cricothyroidotomy