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

Cricothyroidotomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741049
• Other study ID #: 2018-13819
• Status: Completed
• Start date: November 13, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: February 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cricothyroidotomy

Intervention

Device:
• Scalpel Bougie technique (plastic laryngeal model)
ScalpelBougie Set
• Seldinger technique (plastic laryngeal model)
Melker Set
• Surgical technique (plastic laryngeal model)
Scalpel and speculum
• Scalpel Bougie technique (porcine laryngeal model)
ScalpelCric Set
• Surgical technique (porcine laryngeal model)
Scalpel and speculum

Locations

Country	Name	City	State
Germany	Johannes Gutenberg University Medicine Centre Mainz	Mainz	Rhineland Palatine

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check		up to 3 minutes
Secondary	Success rate in the first trial		up to 3 minutes
Secondary	Number of trials		up to 3 minutes
Secondary	Dimension of the tracheal trauma	horizontally and vertically in mm	up to 10 minutes
Secondary	Comfort evaluation by the performer	Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult	up to 15 minutes
Secondary	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
Secondary	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