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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Cricothyroidotomy

Treatments: Device: Scalpel Bougie technique (porcine laryngeal model); Device: Scalpel Bougie technique (plastic laryngeal model); Device: Seldinger technique (plastic laryngeal model); Device: Surgical technique (plastic laryngeal model); Device: Surgical technique (porcine laryngeal model)

Study type: Observational

Funder types: Other

Identifiers

NCT03741049

2018-13819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Consultants

Treatment:

Device: Surgical technique (plastic laryngeal model)

Device: Surgical technique (porcine laryngeal model)

Device: Scalpel Bougie technique (plastic laryngeal model)

Device: Scalpel Bougie technique (porcine laryngeal model)

Device: Seldinger technique (plastic laryngeal model)

Trainee anaesthetists

Treatment:

Device: Surgical technique (plastic laryngeal model)

Device: Surgical technique (porcine laryngeal model)

Device: Scalpel Bougie technique (plastic laryngeal model)

Device: Scalpel Bougie technique (porcine laryngeal model)

Device: Seldinger technique (plastic laryngeal model)

Paramedics

Treatment:

Device: Surgical technique (plastic laryngeal model)

Device: Scalpel Bougie technique (plastic laryngeal model)

Device: Seldinger technique (plastic laryngeal model)

Students

Treatment:

Device: Surgical technique (plastic laryngeal model)

Device: Scalpel Bougie technique (plastic laryngeal model)

Device: Seldinger technique (plastic laryngeal model)