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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06176677
Other study ID # AVNO2024-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2024
Est. completion date March 2, 2024

Study information

Verified date March 2024
Source Azienda USL Toscana Nord Ovest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Videolaryngoscopy has become integral in airway management, providing improved visualization of the glottis and reducing the number of intubation attempts. Proficiency in the use of videolaryngoscopes is essential, particularly in cases of difficult intubation. Videolaryngoscopes equipped with hyperangulated blades facilitate enhanced visualization, even in the most challenging scenarios. However, successful intubation using these blades requires adequate training due to their unique shape. While hyperangulated blades offer excellent views around the curvature of the tongue, their upward perspective from the base of the tongue can pose challenges in tube delivery. Therefore, continuous training is essential to achieve proficiency with these particular blades. Despite the advantages, the high cost of commercially available videolaryngoscopes poses a barrier to regular use and training, especially in resource-limited settings. This study introduces a cost-effective alternative-a self-built laryngoscope using a Universal Serial Bus (USB) borescope. The objective is to compare its training effectiveness with that of a commercial hyperangulated blade videolaryngoscope, underscoring the significance of accessible training options. The Glidescope videolaryngoscope and a custom-built laryngoscope equipped with a USB borescope blade will undergo testing. The evaluation will be conducted by 30 emergency and operating room personnel following a brief training course in videolaryngoscopy, using a LaerdalĀ® intubation mannequin. Both devices will utilize size 4 hyperangulated blades with identical curvature angles. Assessment endpoints will encompass the duration required for glottis visualization and the time needed for the entire intubation process.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: emergency and operating room personnel who have participated and completed the videolaryngoscopy course - Exclusion Criteria: any temporary or permanent physical impediment to performing the requested maneuver or not having participated or completed the videolaryngoscopy course -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Videolaryngoscope
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)
Boroscope
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)

Locations

Country Name City State
Italy Santa Maria Maddalena Hospital Volterra Pisa

Sponsors (1)

Lead Sponsor Collaborator
Azienda USL Toscana Nord Ovest

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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