Teach Intubation by Novices in Anaesthesiology (TeachIntub)

January 24, 2023 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz

Comparision of Direct Laryngoscopy and Video Laryngoscopy to Learn Successful Tracheal Intubation by Novices in Anaesthesiology

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, D55131
        • Recruiting
        • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
        • Contact:
          • Marc Kriege, MD
          • Phone Number: 00496131170

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Videolaryngoscopy (McGrath Macintosh)
First pass success rate using the videolaryngoscopy
Device: Videolarygoscopy
In a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea.
Experimental: conventional direct laryngoscopy
First pass success rate using the conventional direct laryngoscopy
Device: conventional laryngoscopy
In a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First pass success rate
Time Frame: at intubation in 60 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
at intubation in 60 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ventilation
Time Frame: at intubation in 120 seconds
From Insertion of the blase into the mouth until first ventilation
at intubation in 120 seconds
Cormack and Lehane Classification
Time Frame: at intubation in 120 seconds
after insert the device the user describe the glottis visualisation
at intubation in 120 seconds
Overall success rate
Time Frame: at intubation in 120 seconds
after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
at intubation in 120 seconds
Subjective Training Process
Time Frame: at one month
after 25 intubation attempts
at one month

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Marc MK Kriege, PD Dr, University JG, 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)

December 2, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JohannesGUIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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