Place of the Video-laryngoscope in Learning Intubation by... | NCT05859542

Studies
Place of the Video-laryngoscope in Learning Intubation by Simulation

NCT05859542

Sponsor

Mongi Slim Hospital

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Airway Management
Intubation, Intratracheal
Simulation
Laryngoscopy

Interventions

Videolaryngoscope first
Direct laryngoscope first

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jun 27, 2023Actual

Completion Date

Jul 30, 2023Actual

First Submitted Date

Apr 30, 2023

First Submission Date that Met QC Criteria

May 11, 2023

First Posted Date

May 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Videolaryngoscope first	Device	started the session with 3 intubations using the videolaryngoscope	Group A

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fifth year's medical students.
consentment of the participants

Exclusion Criteria:

participants who had previously performed a tracheal intubation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mhamed Sami MS Mebazaa, Pr	Mongi Slim Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mongi Slim hospital		Tunis		2085	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided