Place of the Video-laryngoscope in Learning Intubation by Simulation

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05859542
Collaborator
(none)
35
1
29
36.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 The investigators 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 Design

Study Type:
Observational
Actual Enrollment :
35 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Place of the Video-laryngoscope in Learning Intubation by Simulation
Actual Study Start Date :
Apr 1, 2023
Actual Primary Completion Date :
Apr 27, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. the time needed for the first intubation. [up to 2 minutes]

      Time en seconds needed for the tube to pass through the vocal cords.

    Secondary Outcome Measures

    1. the Cormack-Lehane grade [up to 2 minutes]

      Cormack and Lehane grades (1 to 4)

    2. the satisfaction of the trainees. [up to 24 hours]

      The score of satisfaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • fifth year's medical students.

    • consentment of the participants

    Exclusion Criteria:
    • participants who had previously performed a tracheal intubation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mongi Slim hospital Tunis Tunisia 2085

    Sponsors and Collaborators

    • Mongi Slim Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital
    ClinicalTrials.gov Identifier:
    NCT05859542
    Other Study ID Numbers:
    • Sim intubation
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 16, 2023