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Comparison of a Conventional and a Realistic Self-modified Model

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ClinicalTrials.gov Identifier: NCT04005950
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Pirlich, Dr. med., 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.


Condition or disease Intervention/treatment
Cricothyroidotomy Difficult Airway Obesity Device: Scalpel Bougie technique Device: modified Scalpel Bougie technique

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.


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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation and Comparison of a Modified Skalpell-Bougie-technique for Cricothyreotomie: Comparison of a Conventional and a Realistic Self-modified Model
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 21, 2019
Actual Study Completion Date : July 21, 2019

Group/Cohort Intervention/treatment
medical doctors Device: Scalpel Bougie technique
ScalpelCric Set

Device: modified Scalpel Bougie technique
ScalpelCric Set plus speculum

paramedics Device: Scalpel Bougie technique
ScalpelCric Set

Device: modified Scalpel Bougie technique
ScalpelCric Set plus speculum




Primary Outcome Measures :
  1. evaluation of realistic applicability [ Time Frame: 12 minutes ]
    using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)


Secondary Outcome Measures :
  1. Time from initial handling equipment to a successful placement of the tracheal cannula [ Time Frame: 300 seconds ]

Other Outcome Measures:
  1. Number of trials [ Time Frame: up to 12 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005950


Locations
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Germany
Johannes Gutenberg - Universität
Mainz, Rhineland Palatinate, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz

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Responsible Party: Nina Pirlich, Dr. med., Principle Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04005950     History of Changes
Other Study ID Numbers: ScalpelCric Advanced
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No