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

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.

Study Overview

• Status: Completed
• Conditions: Cricothyroidotomy
• Intervention / Treatment: 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)

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Rhineland Palatine
    • Mainz, Rhineland Palatine, Germany, 55131
      • Johannes Gutenberg University Medicine Centre Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consultants	Device: Scalpel Bougie technique (plastic laryngeal model); ScalpelBougie Set; Device: Seldinger technique (plastic laryngeal model); Melker Set; Device: Surgical technique (plastic laryngeal model); Scalpel and speculum; Device: Scalpel Bougie technique (porcine laryngeal model); ScalpelCric Set; Device: Surgical technique (porcine laryngeal model); Scalpel and speculum
Trainee anaesthetists	Device: Scalpel Bougie technique (plastic laryngeal model); ScalpelBougie Set; Device: Seldinger technique (plastic laryngeal model); Melker Set; Device: Surgical technique (plastic laryngeal model); Scalpel and speculum; Device: Scalpel Bougie technique (porcine laryngeal model); ScalpelCric Set; Device: Surgical technique (porcine laryngeal model); Scalpel and speculum
Paramedics	Device: Scalpel Bougie technique (plastic laryngeal model); ScalpelBougie Set; Device: Seldinger technique (plastic laryngeal model); Melker Set; Device: Surgical technique (plastic laryngeal model); Scalpel and speculum
Students	Device: Scalpel Bougie technique (plastic laryngeal model); ScalpelBougie Set; Device: Seldinger technique (plastic laryngeal model); Melker Set; Device: Surgical technique (plastic laryngeal model); Scalpel and speculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Success rate in the first trial		up to 3 minutes
Number of trials		up to 3 minutes
Dimension of the tracheal trauma	horizontally and vertically in mm	up to 10 minutes
Comfort evaluation by the performer	Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult	up to 15 minutes
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
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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 16, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Airway management; Emergency medicine; CVCI; Cricothyroidotomy
• Other Study ID Numbers: 2018-13819

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No