Comparison of a Conventional and a Realistic Self-modified Model

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Obesity; Cricothyroidotomy; Difficult Airway

Treatments: Device: modified Scalpel Bougie technique; Device: Scalpel Bougie technique

Study type: Observational

Funder types: Other

Identifiers

NCT04005950

ScalpelCric Advanced

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

medical doctors

Treatment:

Device: modified Scalpel Bougie technique

Device: Scalpel Bougie technique

paramedics

Treatment:

Device: modified Scalpel Bougie technique

Device: Scalpel Bougie technique