Comparison of a Conventional and a Realistic Self-modified Model

NCT ID: NCT04005950

Last Updated: 2019-07-23

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-07-21

Brief Summary

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According to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended.

Even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense.

Therefore the investigators modified an available for purchase cricothyroidotomy trainer (the AirSim Combo X) with everyday suitable and cost-effective utensils.

As a control group the investigators used a conventional simple plastic model.

Detailed Description

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Obesity is an important risk factor for a cannot intubate cannot ventilate situation. Obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. Relevant landmarks can be difficult to palpate. And the greater depth of the soft tissues overlying the larynx. Due to this reasons the investigators modified the adult intubation manikin AirSim Combo X with a drunk baby diaper to simulate the neck of an obese patient.

As a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding.

35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model.

For the one time participants use the ScalpelCric Set and for the other time participants use the ScalpelCric Set plus a speculum.

Primary endpoint is the evaluation of reality of the two different manikins.

Conditions

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Cricothyroidotomy Difficult Airway Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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medical doctors

Scalpel Bougie technique

Intervention Type DEVICE

ScalpelCric Set

modified Scalpel Bougie technique

Intervention Type DEVICE

ScalpelCric Set plus speculum

paramedics

Scalpel Bougie technique

Intervention Type DEVICE

ScalpelCric Set

modified Scalpel Bougie technique

Intervention Type DEVICE

ScalpelCric Set plus speculum

Interventions

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Scalpel Bougie technique

ScalpelCric Set

Intervention Type DEVICE

modified Scalpel Bougie technique

ScalpelCric Set plus 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.

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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ScalpelCric Advanced

Identifier Type: -

Identifier Source: org_study_id

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