Clinical Performance and Usability of an AI Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Correct glottis visualization rate (%)
研究概览
简要总结
Background: Orotracheal intubation is an essential procedure in critically ill patients requiring ventilatory support, and the use of videolaryngoscopy is recommended as the gold standard in clinical practice. In recent years, the development of videolaryngoscopes through additive manufacturing has demonstrated lower production costs, and their integration with artificial intelligence (AI) has shown promising results in improving procedural success and safety.
Aim: To evaluate the clinical performance and usability of a videolaryngoscope developed through additive manufacturing and integrated with artificial intelligence (AI) and computer vision, compared with a commercially available gold-standard videolaryngoscope.
Methods: This is a multicenter, randomized, controlled, superiority Phase I/II clinical trial with a single-blind design. A total of 120 critically ill patients admitted to intensive care units at four hospitals in southern Brazil will be enrolled. Participants will be individually randomized in a 1:1 allocation ratio to parallel groups. The interventions will be performed by at least 10 physicians. All physicians will receive standardized training on device use, and procedures will be monitored by trained research staff. Data will be recorded in electronic Excel spreadsheets, and statistical analyses will be conducted using IBM SPSS Statistics. All ethical principles will be strictly observed, including obtaining informed consent from participants or their legal representatives. A Data and Safety Monitoring Committee will be established to oversee the study.
Conclusions: If the expected results are confirmed, patients, healthcare professionals, and healthcare institutions may benefit from the improved performance, safety, and usability of the experimental device, particularly in critical care settings and public health emergencies.
详细描述
Backgorund Orotracheal intubation (OTI) is an essential procedure in critically ill patients requiring mechanical ventilation to maintain gas exchange. It is estimated that OTI is the third most commonly performed procedure in hospitals worldwide, with more than 15 million people intubated annually in surgical centers and 650,000 in other clinical settings, generating over 2.1 billion dollars in global expenditures on intubation and airway protection devices.
Traditionally, a laryngoscope is used for direct visualization of the upper airways and insertion of the endotracheal tube. However, scientific evidence has demonstrated the superiority of videolaryngoscopy (VL), recommending its widespread use in all intubation scenarios as the primary technique in clinical practice.
During the COVID-19 pandemic, given the large number of patients with severe respiratory dysfunction, videolaryngoscopy became essential for managing difficult intubations. In this context, our research team developed a VL prototype using additive manufacturing with polylactic acid (PLA) and carbon fiber-reinforced PLA (PLA-Carbon), validated in realistic simulations for mechanical resistance and usability, with a patent registered at the Brazilian National Institute of Industrial Property (INPI) under number BR 10 2020 026194.
Currently, this VL is being enhanced through the integration of artificial intelligence (AI) using computer vision techniques based on machine learning and deep learning, such as convolutional neural networks, capable of automatically recognizing upper airway anatomical structures from pre-trained images. Given the high demand for orotracheal intubation and the inherent risk of severe complications, the limited availability of videolaryngoscopes due to high import costs in low- and middle-income countries represents a significant gap in care. To address this challenge, the development of a low-cost device using 3D printing combined with artificial intelligence is proposed. This technological integration is justified by its potential to expand access to clinical decision support and enhance procedural safety by providing real-time automated anatomical recognition to the operator.
Primary Objective To evaluate the effectiveness of an experimental videolaryngoscope integrated with artificial intelligence (AI-VL), developed using additive manufacturing, compared with a standard commercial videolaryngoscope (C-VL) during orotracheal intubation in adult patients admitted to the intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician will be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Both sexes.
- •Clinical indication for orotracheal intubation.
- •Both sexes.
- •Working in emergency or ICU settings.
- •Minimum of one year of experience in laryngoscopy and/or orotracheal intubation.
排除标准
- •Clinically unstable or with contraindications to participation in experimental research.
- •Significant airway malformations.
- •Previously intubated or with a functioning tracheostomy.
- •Pregnant.
- •Physicians:
- •On vacation or leave during the study period.
- •Orthopedic, visual, or cognitive limitations that impair participation.
研究组 & 干预措施
Videolaryngoscope 3D with artificial intelligence (VL-AI)
Patients in the intervention group will receive the usual care for orotracheal intubation, differing only in the use of VLP-IA for opening and visualizing the upper airways.
干预措施: Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA). (Device)
Commercially available gold-standard videolaryngoscope (VL-C)
Patients in the comparator group will receive standard care for orotracheal intubation, using the gold-standard VLP-C for airway opening and visualization of the upper airways.
干预措施: Commercially available gold-standard videolaryngoscope (VL-C) (Device)
结局指标
主要结局
Correct glottis visualization rate (%)
时间窗: immediately after insertion of the videolaryngoscope
Refers to the accurate visualization of the glottis and vocal cords on the VL monitor, in agreement with direct visualization - Cormack-Lehane Classification
First-attempt intubation success rate (%)
时间窗: immediately after the first intubation
Defined as the successful establishment of the artificial airway after a single insertion of the VL blade and orotracheal tube.
Number of attempts required for successful intubation (n)
时间窗: immediately after a successful intubation
An attempt is defined as the insertion of the VL blade into the oral cavity, with successful intubation being the correct placement of the tube in the trachea. In the intervention group, up to three attempts with the AI-enhanced VL will be allowed.
Conversion rate to conventional laryngoscope (%)
时间窗: immediately after a failure to use the video laryngoscope
Conversion is defined as the use of a conventional laryngoscope for intubation after discontinuing the use of the allocated VL (intervention or comparator).
次要结局
- Connection time between VL and mobile software (seconds)(Before intubation)
- Glottis visualization time (seconds)(within 60 seconds after insertion of the videolaryngoscope)
- Orotracheal tube insertion time (seconds)(within 60 seconds after intubation)
- Total intubation time (seconds)(within 60 seconds after intubation)
- Adverse events and/or complications rate (%)(during and immediately after intubation)
- Technical incident rate (%)(Before or during the use of the videolaryngoscope)
- Rate of factors associated with intubation failure (%)(During the use of the videolaryngoscope)
- System Usability Scale (SUS)(within 30 minutes after intubation)
- NASA-TLX(within 30 minutes after intubation)
- Questionnaire on physicians' subjective perception(within 30 minutes after intubation)
研究者
Rafael Guerra Lund
Associate Professor PhD
Federal University of Pelotas