Comparison of a Conventional and a Realistic Self-modified Model

Completed

• Conditions: Cricothyroidotomy; Obesity; Difficult Airway
• Interventions: Device: Scalpel Bougie technique; Device: modified Scalpel Bougie technique

• Registration Number: NCT04005950
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-06-30
• Study First Submitted QC: 2019-06-30
• Status Verified: 2019-07
• Study Start: 2019-07-01
• Study First Posted: 2019-07-02
• Primary Completion: 2019-07-21
• Study Completion: 2019-07-21
• Last Update Submitted: 2019-07-21
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
paramedics	modified Scalpel Bougie technique	-
medical doctors	Scalpel Bougie technique	-
medical doctors	modified Scalpel Bougie technique	-
paramedics	Scalpel Bougie technique	-

Primary Outcome Measures

Name	Time	Method
evaluation of realistic applicability	12 minutes	using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)

Secondary Outcome Measures

Name	Time	Method
Time from initial handling equipment to a successful placement of the tracheal cannula	300 seconds

Trial Locations

Locations (1)

Johannes Gutenberg - Universität; 🇩🇪 Mainz, Rhineland Palatinate, Germany