Comparison of AirAngel® vs Storz® Videolaryngoscope and Macintosh® Laryngoscope for Endotracheal Intubation Training: Prospective Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Effectiveness of 3D printed videolaryngoscope
研究概览
简要总结
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.
详细描述
Materials The globally accessible AirAngel® 5.5-mm standard adult laryngoscope model was chosen as the 3D-PVL blade model. AirAngel® is a 3D-PVL model produced with 3D printing technology, the digital file of which has been opened to public access by its designers, which has a hyper-angulated blade and allows transferring the images to devices such as a phone, computer, or tablet with an integrated endoscope camera. The AirAngel® 3D 5.5-mm standard adult laryngoscope model was printed with 3D printer at Acibadem Mehmet Ali Aydinlar University Incubation Center in 80% density and as five layers from polylactic acid (PLA) material. The indentation at the end of the printed laryngoscope was suitable for integrating a 5.5-mm diameter camera (endoscope). The PLA material used in printing costs approximately 6 USD.
We mounted a 5.5-mm diameter, light-emitting diode (LED)-illuminated, International Protection Code (IP)67-certified, and water-resistant endoscope camera with a resolution of 640 × 480 pixels equipped with a 1/9 inch complementary metal oxide semiconductor sensor and 1-m long universal serial bus (USB) connection to the printed laryngoscope for approximately 9 USD. The created 3D-PVL was connected to a smart phone compatible with USB On-The-Go, which is a feature that allows the phone to be used as a host allowing the use of other USB devices, with a 6.67-inch in-plane switching liquid crystal display with a resolution of 1080 × 2400 full high definition+ pixels. A smart phone-supported 3D-PVL was obtained in this way.
A standard MCL and Storz® VL (SVL) monitor was selected as the DL and VL devices to be compared with 3D-PVL, respectively. A size 3 Macintosh blade, which is the most commonly used in adults and compatible with 3D-PVL dimensions and design, was preferred for both MCL and SVL.
The tongue of the manikin was fully inflated with 10 mL of air when the manikin was being used as a difficult airway manikin (DAM), and the cervical spine screw was fully tightened to reduce head extension. No modifications were made when the manikin was used as a normal airway manikin (NAM). An endotracheal tube (ETT) with a standard 7.5-mm inner diameter was chosen. The stylet was placed in the ETT before the intervention. A new ETT and stylet were used in each intervention. Additionally, the ETTs were lubricated before each intervention.
Participants The study participant consisted of senior students enrolled in Acibadem Mehmet Ali Aydinlar University Faculty of Medicine. The study was conducted at the Center of Advanced Simulation and Education (CASE) laboratory. The senior medical school students (SMSS) were invited via e-mail by the medical education coordination office of the university from November 2020 to January 2022. SMSS were invited four times in total, twice in each academic year. Informed consent and study plan were shared within the invitation e-mail. The e-mail stated that this study would not be graded, it would not have any effect on school success, participation is not compulsory, and they can participate in the study by making an appointment with CASE at any time during the academic year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being senior medical students Not having received endotracheal intubation training
排除标准
- •Refusal to participate in the study
结局指标
主要结局
Effectiveness of 3D printed videolaryngoscope
时间窗: Two years
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.
次要结局
- The effectiveness of using a 3D printed videolaryngoscope during endotracheal intubation training.(Two years)