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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03741049
Enrollment
200
Registered
2018-11-14
Start date
2018-11-13
Completion date
2018-12-20
Last updated
2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cricothyroidotomy

Keywords

CVCI, Emergency medicine, Airway management, Cricothyroidotomy

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.

Interventions

DEVICEScalpel Bougie technique (plastic laryngeal model)

ScalpelBougie Set

DEVICESeldinger technique (plastic laryngeal model)

Melker Set

DEVICESurgical technique (plastic laryngeal model)

Scalpel and speculum

DEVICEScalpel Bougie technique (porcine laryngeal model)

ScalpelCric Set

DEVICESurgical technique (porcine laryngeal model)

Scalpel and speculum

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position checkup to 3 minutes

Secondary

MeasureTime frameDescription
Number of trialsup to 3 minutes
Dimension of the tracheal traumaup to 10 minuteshorizontally and vertically in mm
Success rate in the first trialup to 3 minutes
Influence of training on the time to decision making for cricothyrotomyup to 5 hoursAfter 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.
Influence of training on choosing the techniqueup to 5 hoursAfter 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.
Comfort evaluation by the performerup to 15 minutesLikert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026