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.
Age ≥18 years.
Both sexes.
Clinical indication for orotracheal intubation.
Both sexes.
Clinically unstable or with contraindications to participation in experimental research.
Significant airway malformations.
Previously intubated or with a functioning tracheostomy.
Pregnant.
Parallel
Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA).
DeviceThe 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)
DeviceScientific 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.
Correct glottis visualization rate (%)
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 (%)
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)
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 (%)
Conversion is defined as the use of a conventional laryngoscope for intubation after discontinuing the use of the allocated VL (intervention or comparator).
Connection time between VL and mobile software (seconds)
Measured from the moment the VL is handed to the bedside physician until the real-time image is displayed on the monitor, captured with the blade still outside the oral cavity.
Glottis visualization time (seconds)
Time from the insertion of the VL blade into the oral cavity until the glottis is visualized on the monitor, verbally confirmed by the physician.
Orotracheal tube insertion time (seconds)
Time from the adequate visualization of the glottis and vocal cords to the complete insertion of the tube into the trachea, with removal of the VL from the oral cavity.
Total intubation time (seconds)
Time from the first insertion of the VL into the oral cavity to the successful placement of the orotracheal tube in the trachea, regardless of the number of attempts or device changes.
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Federal University of Pelotas
Lead sponsor
Universidade Federal de Santa Catarina
Collaborator
Universidade Católica de Pelotas
Collaborator
Universidade Federal do Rio Grande (FURG)
Collaborator
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