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

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ClinicalTrials.gov Identifier: NCT03741049
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Pirlich, Dr. med., 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.


Condition or disease Intervention/treatment
Cricothyroidotomy 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.


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741049


Locations
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Germany
Johannes Gutenberg University Medicine Centre Mainz
Mainz, Rhineland Palatine, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz

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Responsible Party: Nina Pirlich, Dr. med., Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT03741049     History of Changes
Other Study ID Numbers: 2018-13819
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz:
CVCI
Emergency medicine
Airway management
Cricothyroidotomy