Introduction larynGuide™ is a novel assistive software integrated with the C-MAC® videolaryngoscope, which provides guidance during laryngoscopy and advises on tracheal tube position. This first in-human study evaluated the accuracy and reliability of larynGuide compared with the judgment of the airway operator.Methods This prospective, single-centre, investigator-initiated, observational study included adult patients undergoing elective surgery requiring general anaesthesia with tracheal intubation. After informed consent and standardised induction of anaesthesia, laryngoscopy and tracheal intubation were performed with a C-MAC® videolaryngoscope with a Macintosh blade by a board-certified anaesthetist. larynGuide ran on a second screen, visible only to the study team but blinded to the airway operator. After tracheal intubation attempts, the airway operator confirmed tracheal tube placement visually and with capnography. The primary outcome was the real-time accuracy of larynGuide in identifying correct tracheal tube placement.Results We enrolled 132 patients, of whom 110 were analysed. Of 108 patients with correctly placed tracheal tubes, larynGuide identified 102 (sensitivity 0.94, 95%CI 0.88-0.98). In six patients, the software misclassified tracheal tube position: two false negatives (i.e. the software advised a failed tracheal intubation despite correct placement); and four patients with no feedback. Among two patients with unsuccessful tracheal intubation due to oesophageal tube placement at the first attempt, larynGuide detected one.Discussion This first in-human study has established the feasibility of AI-guided real-time tracheal intubation using larynGuide. The software showed promising sensitivity, while specificity was limited. Videolaryngoscopy image quality issues, including fogging and poor visibility, impaired the performance of the software.larynGuide™ is a new computer program that works with a special camera tool called the C‐MAC® videolaryngoscope. It helps doctors see the throat more clearly and gives advice on where to place a breathing tube. This study tested how accurate and reliable larynGuide was compared to the doctor's own judgment. The study included adults having planned surgery that needed general anaesthesia and a breathing tube. After patients gave permission, a trained doctor used the C‐MAC® videolaryngoscope to place the breathing tube. The larynGuide software ran on a separate screen that only the research team could see. The doctor did not see the software's advice. After putting in the breathing tube, the doctor checked that it was in the right place using sight a test called capnography that measures carbon dioxide in the patient's breath. The main goal was to see how often larynGuide correctly identified the right tube placement. In total, 132 patients joined the study, and 110 were included in the final results. Of the 108 patients who had their breathing tubes correctly placed, larynGuide also showed correct placement in 102 of them. This means the software was right about 94% of the time. In six cases, the software was wrong or did not give an answer. In two patients where the tube went into the wrong place (the food pipe instead of the windpipe), larynGuide identified one of them. This was the first study to test using larynGuide in real people. The software worked well most of the time and showed that computer help during breathing tube placement is possible. However, it did make some mistakes, especially when the camera view was blocked or blurry.
