Evaluation of the ScalpelCric Set and Comparison With Two Further Techniques of Cricothyrotomy
- Conditions
- Cricothyroidotomy
- Interventions
- Device: Scalpel Bougie technique (plastic laryngeal model)Device: Seldinger technique (plastic laryngeal model)Device: Surgical technique (plastic laryngeal model)Device: Scalpel Bougie technique (porcine laryngeal model)Device: Surgical technique (porcine laryngeal model)
- Registration Number
- NCT03741049
- Lead Sponsor
- Johannes Gutenberg University 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- written informed consent
- German language in speaking and writing
- Capability of giving consent
- Participants unwilling or unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trainee anaesthetists Scalpel Bougie technique (porcine laryngeal model) - Trainee anaesthetists Surgical technique (plastic laryngeal model) - Consultants Surgical technique (plastic laryngeal model) - Consultants Surgical technique (porcine laryngeal model) - Trainee anaesthetists Surgical technique (porcine laryngeal model) - Paramedics Seldinger technique (plastic laryngeal model) - Paramedics Surgical technique (plastic laryngeal model) - Consultants Seldinger technique (plastic laryngeal model) - Trainee anaesthetists Scalpel Bougie technique (plastic laryngeal model) - Paramedics Scalpel Bougie technique (plastic laryngeal model) - Students Seldinger technique (plastic laryngeal model) - Consultants Scalpel Bougie technique (plastic laryngeal model) - Consultants Scalpel Bougie technique (porcine laryngeal model) - Trainee anaesthetists Seldinger technique (plastic laryngeal model) - Students Scalpel Bougie technique (plastic laryngeal model) - Students Surgical technique (plastic laryngeal model) -
- Primary Outcome Measures
Name Time Method Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check up to 3 minutes
- Secondary Outcome Measures
Name Time Method Number of trials up to 3 minutes Comfort evaluation by the performer up to 15 minutes Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult
Dimension of the tracheal trauma up to 10 minutes horizontally and vertically in mm
Success rate in the first trial up to 3 minutes Influence of training on the time to decision making for cricothyrotomy up to 5 hours 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.
Influence of training on choosing the technique up to 5 hours 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.
Trial Locations
- Locations (1)
Johannes Gutenberg University Medicine Centre Mainz
🇩🇪Mainz, Rhineland Palatine, Germany