Place of the Video-laryngoscope in Learning Intubation by Simulation

The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.

The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. The first part of our session consisted in a theoretical training. The second part was the practical training with procedural simulation.

Study Overview

• Status: Completed
• Conditions: Simulation; Airway Management; Laryngoscopy; Intubation, Intratracheal
• Intervention / Treatment: Device: Videolaryngoscope first; Device: Direct laryngoscope first

Detailed Description

Simulation is nowadays a widespread teaching method, particularly in airway management. The direct laryngoscope is the most commonly used device for learning intubation. As for the videolaryngoscope, it is mostly used on an advanced level, for teaching difficult laryngoscopy to professionals. Its impact on teaching intubation to beginners remains unclear.

The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.

The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. They included 35 trainees.

The first part of our session consisted in a theoretical training, during which one single instructor exposed the anatomical basis and the material needed: a direct laryngoscope (Macintosh) with a number 3 curved blade, a videolaryngoscope (Med-Captain) with a number 3 curved blade and a number 7 tracheal tube with a stylet.

The second part was the practical training with procedural simulation. The investigators randomized the trainees in two groups.

Each trainee proceeded to three intubations with each device, in the specified order.

The investigators used the SPSS software for data analysis. The investigators considered a p-value < 0.05 as statistically significant.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 2085
    • Mongi Slim Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

We included 35 trainees. they were aged between 22 and 24 years old.

Description

Inclusion Criteria:

• fifth year's medical students.
• consentment of the participants

Exclusion Criteria:

• participants who had previously performed a tracheal intubation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; The group A included 18 trainees, who started the session with videolaryngoscope followed by the direct laryngoscope.	Device: Videolaryngoscope first; started the session with 3 intubations using the videolaryngoscope; Other Names: VL
Group B; The group B included 17 trainees, who started the session with the direct laryngoscope followed by the videolaryngoscope.	Device: Direct laryngoscope first; started the session with 3 intubations using the Direct laryngoscope; Other Names: DL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time needed for the first intubation.	Time en seconds needed for the tube to pass through the vocal cords.	up to 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Cormack-Lehane grade	Cormack and Lehane grades (1 to 4)	up to 2 minutes
the satisfaction of the trainees.	The score of satisfaction	up to 24 hours

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: April 30, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Sim intubation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No