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NCT Number: NCT03741049

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

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.

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Key information

Conditions

Cricothyroidotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johannes Gutenberg University Medicine Centre Mainz

Mainz, Rhineland Palatine, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalpel Bougie technique (plastic laryngeal model)

Device

ScalpelBougie Set

Seldinger technique (plastic laryngeal model)

Device

Melker Set

Surgical technique (plastic laryngeal model)

Device

Scalpel and speculum

Scalpel Bougie technique (porcine laryngeal model)

Device

ScalpelCric Set

Surgical technique (porcine laryngeal model)

Device

Scalpel and speculum

Primary outcomes

  1. Time from initially handling equipment to a successful placement of the endotracheal tube verified by a fiberoptic position check

    Time frame: up to 3 minutes

Secondary outcomes

  1. Success rate in the first trial

    Time frame: up to 3 minutes

  2. Number of trials

    Time frame: up to 3 minutes

  3. Dimension of the tracheal trauma

    Time frame: up to 10 minutes

    horizontally and vertically in mm

  4. Comfort evaluation by the performer

    Time frame: up to 15 minutes

    Likert-Scale: 1=very easy, 2=easy, 3=difficult, 4=very difficult

  5. Influence of training on the time to decision making for cricothyrotomy

    Time frame: 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.

  6. Influence of training on choosing the technique

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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