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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05859542
Other study ID # Sim intubation
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date July 30, 2023

Study information

Verified date September 2023
Source Mongi Slim Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date July 30, 2023
Est. primary completion date June 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 24 Years
Eligibility Inclusion Criteria: - fifth year's medical students. - consentment of the participants Exclusion Criteria: - participants who had previously performed a tracheal intubation.

Study Design


Intervention

Device:
Videolaryngoscope first
started the session with 3 intubations using the videolaryngoscope
Direct laryngoscope first
started the session with 3 intubations using the Direct laryngoscope

Locations

Country Name City State
Tunisia Mongi Slim hospital Tunis

Sponsors (1)

Lead Sponsor Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the Cormack-Lehane grade Cormack and Lehane grades (1 to 4) up to 2 minutes
Secondary the satisfaction of the trainees. The score of satisfaction up to 24 hours
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