The Performance of AirAngel® Videolaryngoscope

NCT06091644 | Completed

• 1 other identifier: ATADEK, 2020-25/22
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Videolaryngoscope; 3-D printing; 3-Dimensional Printing

Outcome Measures

Primary Outcomes (1)

• Effectiveness of 3D printed videolaryngoscope

  It 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 intubation success. Accurate ETT placement was evaluated by visual confirmation of the swelling of the lungs on the manikin. The intubation attempt was considered unsuccessful if the manikin's stomach was filled with air. Conversely, the intubation attempt was considered successful if one or both lungs were filled with air. An unsuccessful intubation attempt is considered a failure of three or more intubation attempts by an experienced user, or the failure of the patient to maintain an airway when a permanent airway is required immediately.

  Two years

Secondary Outcomes (1)

• The effectiveness of using a 3D printed videolaryngoscope during endotracheal intubation training.

  Two years

Study Arms (1)

Evaluation of device performances in normal and difficult airway management

OTHER

Each endotracheal intubation (ETI) attempt could enhance the participant's experience in the next attempt. Hence, the order of use of ETI devices was randomized to avoid experience-based bias. Six subgroups were needed to determine the order in which the SMSS would use the devices based on a permutation of three because three ETI devices were planned to be used in total. Accordingly, participants were randomized into six groups using the Random Team Generator. Six experiment stations were set up. Normal airway manikins (NAMs) were used in the first three stations, and difficult airway manikins (DAMs) were used in the subsequent three. The interventions were to be conducted by the participants using NAMs first, followed by DAMs in the predetermined randomization order. Participants were assisted by an experienced assistant researcher in ETI during their attempts to extend the ETT, who also check the intubation accuracy with a bag valve mask (BVM) at the end of the intervention.

Device: AirAngel® 3D printed videolaryngoscope

Interventions

AirAngel® 3D printed videolaryngoscope DEVICE

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.

Also known as: Storz® videolaryngoscope and, Macintosh® laryngoscope

Evaluation of device performances in normal and difficult airway management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being senior medical students Not having received endotracheal intubation training

You may not qualify if:

• Refusal to participate in the study

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (6)

• Pieters BMA, Maas EHA, Knape JTA, van Zundert AAJ. Videolaryngoscopy vs. direct laryngoscopy use by experienced anaesthetists in patients with known difficult airways: a systematic review and meta-analysis. Anaesthesia. 2017 Dec;72(12):1532-1541. doi: 10.1111/anae.14057. Epub 2017 Sep 22.

  PMID: 28940354 BACKGROUND

• Maruyama K, Yamada T, Kawakami R, Hara K. Randomized cross-over comparison of cervical-spine motion with the AirWay Scope or Macintosh laryngoscope with in-line stabilization: a video-fluoroscopic study. Br J Anaesth. 2008 Oct;101(4):563-7. doi: 10.1093/bja/aen207. Epub 2008 Jul 25.

  PMID: 18660500 BACKGROUND

• Zaouter C, Calderon J, Hemmerling TM. Videolaryngoscopy as a new standard of care. Br J Anaesth. 2015 Feb;114(2):181-3. doi: 10.1093/bja/aeu266. Epub 2014 Aug 23. No abstract available.

  PMID: 25150988 BACKGROUND

• Lambert CT, John SC, John AV. Development and performance testing of the low-cost, 3D-printed, smartphone-compatible 'Tansen Videolaryngoscope' vs. Pentax-AWS videolaryngoscope vs. direct Macintosh laryngoscope: A manikin study. Eur J Anaesthesiol. 2020 Nov;37(11):992-998. doi: 10.1097/EJA.0000000000001264.

  PMID: 32675700 BACKGROUND

• Cook TM, Kelly FE. A national survey of videolaryngoscopy in the United Kingdom. Br J Anaesth. 2017 Apr 1;118(4):593-600. doi: 10.1093/bja/aex052.

  PMID: 28403414 BACKGROUND

• Coles-Black J, Chao I, Chuen J. Three-dimensional printing in medicine. Med J Aust. 2017 Aug 7;207(3):102-103. doi: 10.5694/mja16.01073. No abstract available.

  PMID: 28764624 BACKGROUND

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Kamil Kayayurt, Ass Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)