AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA).: The videolaryngoscope (VL) incorporates a microcamera at the tip of the blade, enabling real-time visualization of anatomical structures via a monitor. The VL to be used in the intervention was manufactured through additive manufacturing using polylactic acid (PLA) and polyethylene terephthalate glycol (PETG). It was validated in high-fidelity simulations for mechanical strength and usability and is patented under number BR 10 2020 026194 with the Brazilian National Institute of Industrial Property (INPI). The VL is currently being enhanced through the integration of artificial intelligence (AI) using computer vision techniques based on Machine Learning and Deep Learning, including convolutional neural networks capable of automatically recognizing upper airway anatomical structures from previously trained image datasets. The embedded system will provide real-time visual and audio guidance during intubation with less than one-second latency.

Commercially available gold-standard videolaryngoscope (VL-C): Scientific evidence recommends the use of VL in all cases of intubation, across various clinical scenarios, as the primary intubation technique in clinical practice. The videolaryngoscope incorporates a microcamera at the tip of the blade, allowing visualization of anatomical structures in real time via a monitor.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Correct glottis visualization rate (%) — 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 (%) — 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) — 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 (%) — 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).

Trial sites (4)

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