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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05145556
Other study ID # JohannesGUIT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2, 2021
Est. completion date February 1, 2024

Study information

Verified date January 2023
Source Johannes Gutenberg University Mainz
Contact Marc MK Kriege, PD Dr
Phone 00496131170
Email MaKriege@uni-mainz.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology


Description:

Video laryngoscopy has been recommended as an alternative during difficult conventional direct laryngoscopy using the Macintosh blade. However, successful visualisation of the larynx and tracheal intubation using some of the indirect laryngoscopes or video laryngoscopy requires hand-eye coordination. To best of our knowledge in the current literature there are no data how is the best educative way to learn successful tracheal intubation by novices in anaesthesiology.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date February 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Age = 18 Years - capacity to consent - Present written informed consent of the research participant Exclusion Criteria: - Age <18 years - Lack of consent - inability to consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Videolarygoscopy
In a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea.
conventional laryngoscopy
In a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Locations

Country Name City State
Germany Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University Mainz Rhineland-Palatinate

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary First pass success rate successful tracheal intubation at the first attempt, compared to more than one attempt at intubation in 60 seconds
Secondary Time to ventilation From Insertion of the blase into the mouth until first ventilation at intubation in 120 seconds
Secondary Cormack and Lehane Classification after insert the device the user describe the glottis visualisation at intubation in 120 seconds
Secondary Overall success rate after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask) at intubation in 120 seconds
Secondary Subjective Training Process after 25 intubation attempts at one month
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