Comparison of a Conventional and a Realistic Self-modified Model

Obesity Clinical Trial

Official title:

Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005950
• Other study ID #: ScalpelCric Advanced
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: July 21, 2019

Study information

• Verified date: July 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 21, 2019
• Est. primary completion date: July 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cricothyroidotomy
• Difficult Airway
• Obesity

Intervention

Device:
• Scalpel Bougie technique
ScalpelCric Set
• modified Scalpel Bougie technique
ScalpelCric Set plus speculum

Locations

Country	Name	City	State
Germany	Johannes Gutenberg - Universität	Mainz	Rhineland Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of trials		up to 12 minutes
Primary	evaluation of realistic applicability	using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)	12 minutes
Secondary	Time from initial handling equipment to a successful placement of the tracheal cannula		300 seconds