- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176677
Use of a Low-cost Video Laryngoscope on Manikin
Comparative Evaluation of Training Effectiveness Between Commercial Videolaryngoscope and Low-Cost Self Built Laryngoscope With Hyperangulated Blade
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Laerdal® 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pisa
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Volterra, Pisa, Italy, 56048
- Santa maria maddalena Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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compare the effectiveness of training between a commercial videolaryngoscope and a low cost videolaryngoscope
Time Frame: one hour
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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 .
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one hour
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alessandro Tani, MD, area Vasta Toscana Nordovest
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AVNO2024-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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