NCT04005950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

20 days

First QC Date

June 30, 2019

Last Update Submit

July 21, 2019

Conditions

CricothyroidotomyDifficult AirwayObesity

Outcome Measures

Primary Outcomes (1)

  • evaluation of realistic applicability

    using Likert scale (1=very realistic, 2= realistic, 3= not very realistic, 4=unrealistic)

    12 minutes

Secondary Outcomes (1)

  • Time from initial handling equipment to a successful placement of the tracheal cannula

    300 seconds

Other Outcomes (1)

  • Number of trials

    up to 12 minutes

Study Arms (2)

medical doctors

Device: Scalpel Bougie techniqueDevice: modified Scalpel Bougie technique

paramedics

Device: Scalpel Bougie techniqueDevice: modified Scalpel Bougie technique

Interventions

Scalpel Bougie techniqueDEVICE

ScalpelCric Set

medical doctorsparamedics
modified Scalpel Bougie techniqueDEVICE

ScalpelCric Set plus speculum

medical doctorsparamedics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • written informed consent
  • german language in speaking and writing
  • capability of giving consent

You may not qualify if:

  • participants unwilling or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

July 1, 2019

Primary Completion

July 21, 2019

Study Completion

July 21, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

DE(1)