Comparison of a Conventional and a Realistic Self-modified Model

July 21, 2019 updated by: Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland Palatinate
      • Mainz, Rhineland Palatinate, Germany, 55131
        • Johannes Gutenberg - Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

medical doctors of the Department of anesthesiology of the University hospital Mainz, Germany

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of realistic applicability
Time Frame: 12 minutes
using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)
12 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from initial handling equipment to a successful placement of the tracheal cannula
Time Frame: 300 seconds
300 seconds

Other Outcome Measures

Outcome Measure
Time Frame
Number of trials
Time Frame: up to 12 minutes
up to 12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

July 21, 2019

Study Completion (ACTUAL)

July 21, 2019

Study Registration Dates

First Submitted

June 30, 2019

First Submitted That Met QC Criteria

June 30, 2019

First Posted (ACTUAL)

July 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ScalpelCric Advanced

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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