Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT04005950
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Conventional and a Realistic Self-modified Model
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Study Overview
Official Title:
Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: