NCT06176677

Brief Summary

Videolaryngoscopy has become essential in airway management, providing improved glottis visualization and reducing intubation attempts. Proficiency in using videolaryngoscopes, especially those with hyperangulated blades, is crucial for challenging intubation cases. However, successful intubation with hyperangulated blades requires continuous training due to their unique shape. Despite the benefits, the high cost of commercial videolaryngoscopes limits their use, prompting the exploration of a cost-effective alternative-a self-built laryngoscope using a USB borescope. The study aims to compare its training effectiveness with a commercial hyperangulated blade videolaryngoscope, emphasizing accessible training options. The evaluation involves testing both devices on a Laerdal® intubation mannequin, focusing on the time to glottis visualization and the time to complete intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

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

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

15 days

First QC Date

December 11, 2023

Last Update Submit

March 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • compare the effectiveness of training between a commercial videolaryngoscope and a low cost videolaryngoscope

    Compare the training effectiveness between a commercial videolaryngoscope and a low-cost videolaryngoscope by measuring the time from the insertion of each laryngoscope through the mouth to the complete visualization of the glottis (T1) and the time taken for the entire intubation maneuver (T2) in the manikin, among 30 emergency and operating room operators .

    one hour

Interventions

We set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2)

BoroscopeDEVICE

We set as endpoint the time from insertion of each laryngoscope through the mouth to complete visualization of the glottis (T1) and the time to complete intubation manoeuvre(T2)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 doctors and nurses in the emergency area and operating room

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Maria Maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (1)

  • Tani A, Vagheggini G, Tudisco S, Del Colombo V, Mannelli E, Lehle J. Use of low-cost modified laryngoscope for training in videolaryngoscopy. A comparison between a Macintosh modified laryngoscope and Stortz C MAC 8403XDK: a manikin study. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):85-86. doi: 10.23736/S0375-9393.21.15998-X. Epub 2021 Sep 16. No abstract available.

    PMID: 34527409BACKGROUND

Study Officials

  • Alessandro Tani, MD

    area Vasta Toscana Nordovest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

February 15, 2024

Primary Completion

March 1, 2024

Study Completion

March 2, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations