Clinical trial NCT03741049: Evaluation of the ScalpelCric Set and Comparison With Two Further Techniques of Cricothyrotomy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cricothyroidotomy
Keywords: CVCI
Emergency medicine
Airway management
Cricothyroidotomy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students (University Mainz), paramedics (DRK, MHD, ASB, ADAC), trainee anaesthetists and consultants (Department of anaesthesiology University hospital Mainz)

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check
timeFrame: up to 3 minutes
Secondary outcomes:
measure: Success rate in the first trial
timeFrame: up to 3 minutes
measure: Number of trials
timeFrame: up to 3 minutes
measure: Dimension of the tracheal trauma
timeFrame: up to 10 minutes
measure: Comfort evaluation by the performer
timeFrame: up to 15 minutes
measure: Influence of training on the time to decision making for cricothyrotomy
timeFrame: up to 5 hours
measure: Influence of training on choosing the technique
timeFrame: up to 5 hours
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg University Medicine Centre Mainz
state: Rhineland Palatine
Study officials:
References: