The Performance of AirAngel® Videolaryngoscope

NCT06091644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-10-19

No results posted yet for this study

Summary

Video laryngoscopy (VL) have certain advantages over other techniques, such as better glottic imaging, higher intubation success in individuals with difficult airways, less force required for intubation, less cervical spine movement, and better image capturing overall. Some experts have recently suggested that the VL should be accepted and used as the standard technique for imaging in all emergency intubations, not just difficult intubations. However, VL is often not accessible in low-income countries because of its high costs. Additionally, hospitals may not be able to reach the devices even if they can cover the cost in cases where the demand is excessive.

Three dimensional (3D) printing is the technology of producing objects in 3D from an existing or designed digital file. This rapidly developing technology is already used in many areas of daily life and has also been widely used in medical applications. 3D printers produce many expensive medical materials and devices at lower costs, enable personalized modeling (implants and prostheses), tissue cultures, and surgical planning, and can also be used as educational material. One of these applications is 3D-printed VL (3D-PVL), which has become prominent in pandemic conditions. A 3D-PVL can be obtained for only 6-30 United States dollars (USD) compared to a VL that costs thousands of US dollars.

Moreover, a study comparing 3D-PVL with standard VL in difficult airway management for experienced practitioners demonstrated comparable success rates in both devices. Furthermore, the VL created by modifying a Macintosh® laryngoscope (MCL) with an endoscope camera was reported superior to the standard MCL and comparable to the standard VL in the hands of experienced users. However, the literature presented no study that evaluated the efficiency of 3D-PVLs in inexperienced practitioners. Herein, our study aimed to investigate the effectiveness of 3D-PVLs in acquiring endotracheal intubation (ETI) skills in senior medical school students who are inexperienced users and compare 3D-PVL with standard MCL and VL.

Conditions

  • Educational Problems
  • Financial Hardship

Interventions

DEVICE

AirAngel® 3D printed videolaryngoscope

This is a mannequin study that aims to compare a videolaryngoscope produced with 3D printing with a Storz videolaryngoscope and a Macintosh direct laryngoscope in the hands of inexperienced users in terms of ease of use, glottic imaging and intubation success.

Sponsors & Collaborators

  • Acibadem University

    lead OTHER

Principal Investigators

  • Kamil Kayayurt, Ass Prof · Acibadem University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-01-31
Completion
2022-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091644 on ClinicalTrials.gov