NCT05859542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

26 days

First QC Date

April 30, 2023

Last Update Submit

September 23, 2023

Conditions

Airway ManagementIntubation, IntratrachealSimulationLaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the Cormack-Lehane grade

    up to 2 minutes

  • the satisfaction of the trainees.

    up to 24 hours

Study Arms (2)

Group A

The group A included 18 trainees, who started the session with videolaryngoscope followed by the direct laryngoscope.

Device: Videolaryngoscope first

Group B

The group B included 17 trainees, who started the session with the direct laryngoscope followed by the videolaryngoscope.

Device: Direct laryngoscope first

Interventions

Videolaryngoscope firstDEVICE

started the session with 3 intubations using the videolaryngoscope

Also known as: VL
Group A
Direct laryngoscope firstDEVICE

started the session with 3 intubations using the Direct laryngoscope

Also known as: DL
Group B

Eligibility Criteria

Age22 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • participants who had previously performed a tracheal intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

Location

Study Officials

  • Mhamed Sami MS Mebazaa, Pr

    Mongi Slim Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 16, 2023

Study Start

June 1, 2023

Primary Completion

June 27, 2023

Study Completion

July 30, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

TU(1)