TeachIntub: Teach Intubation by Novices in Anaesthesiology

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05145556

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Learning Problem Larynx	Device: Videolarygoscopy Device: conventional laryngoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Starting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubationsStarting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubations

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 2, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

First pass success rate [at intubation in 60 seconds]
successful tracheal intubation at the first attempt, compared to more than one attempt

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate	Germany	D55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

Principal Investigator: Marc MK Kriege, PD Dr, University JG, Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marc Kriege, MD, PD Dr. med., Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT05145556

Other Study ID Numbers:

JohannesGUIT

First Posted:

Dec 6, 2021

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marc Kriege, MD, PD Dr. med., Johannes Gutenberg University Mainz

Tracheal Intubation, Learning Technique, Laryngoscope

Study Results

No Results Posted as of Mar 29, 2022