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Comparison of a Conventional and a Realistic Self-modified Model

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04005950
Enrollment
70
Registered
2019-07-02
Start date
2019-07-01
Completion date
2019-07-21
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cricothyroidotomy, Difficult Airway, Obesity

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.

Interventions

DEVICEScalpel Bougie technique

ScalpelCric Set

DEVICEmodified Scalpel Bougie technique

ScalpelCric Set plus speculum

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
evaluation of realistic applicability12 minutesusing Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)

Secondary

MeasureTime frame
Time from initial handling equipment to a successful placement of the tracheal cannula300 seconds

Other

MeasureTime frame
Number of trialsup to 12 minutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026