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

NCT ID: NCT03741049

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-13

Study Completion Date

2018-12-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cricothyroidotomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Consultants

Scalpel Bougie technique (plastic laryngeal model)

Intervention Type DEVICE

ScalpelBougie Set

Seldinger technique (plastic laryngeal model)

Intervention Type DEVICE

Melker Set

Surgical technique (plastic laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Scalpel Bougie technique (porcine laryngeal model)

Intervention Type DEVICE

ScalpelCric Set

Surgical technique (porcine laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Trainee anaesthetists

Scalpel Bougie technique (plastic laryngeal model)

Intervention Type DEVICE

ScalpelBougie Set

Seldinger technique (plastic laryngeal model)

Intervention Type DEVICE

Melker Set

Surgical technique (plastic laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Scalpel Bougie technique (porcine laryngeal model)

Intervention Type DEVICE

ScalpelCric Set

Surgical technique (porcine laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Paramedics

Scalpel Bougie technique (plastic laryngeal model)

Intervention Type DEVICE

ScalpelBougie Set

Seldinger technique (plastic laryngeal model)

Intervention Type DEVICE

Melker Set

Surgical technique (plastic laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Students

Scalpel Bougie technique (plastic laryngeal model)

Intervention Type DEVICE

ScalpelBougie Set

Seldinger technique (plastic laryngeal model)

Intervention Type DEVICE

Melker Set

Surgical technique (plastic laryngeal model)

Intervention Type DEVICE

Scalpel and speculum

Interventions

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Scalpel Bougie technique (plastic laryngeal model)

ScalpelBougie Set

Intervention Type DEVICE

Seldinger technique (plastic laryngeal model)

Melker Set

Intervention Type DEVICE

Surgical technique (plastic laryngeal model)

Scalpel and speculum

Intervention Type DEVICE

Scalpel Bougie technique (porcine laryngeal model)

ScalpelCric Set

Intervention Type DEVICE

Surgical technique (porcine laryngeal model)

Scalpel and speculum

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Nina Pirlich, Dr. med.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes Gutenberg University Medicine Centre Mainz

Mainz, Rhineland Palatine, Germany

Site Status

Countries

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Germany

Other Identifiers

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2018-13819

Identifier Type: -

Identifier Source: org_study_id

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