NCT03741049

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cricothyroidotomy

Interventions

Type	Name	Description
DEVICE	Scalpel Bougie technique (plastic laryngeal model)	ScalpelBougie Set
DEVICE	Seldinger technique (plastic laryngeal model)	Melker Set
DEVICE	Surgical technique (plastic laryngeal model)	Scalpel and speculum
DEVICE	Scalpel Bougie technique (porcine laryngeal model)	ScalpelCric Set
DEVICE	Surgical technique (porcine laryngeal model)	Scalpel and speculum

Timeline

• Start date: 2018-11-13
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2018-11-14
• Last updated: 2019-02-19

Locations

1 site across 1 country: Germany