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.
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.
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.
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.
We thank Shah et al. for their comments [1] on the updated Association of Anaesthetists' safe vascular access guideline [2]. The lack of robust clinical evidence to support platelet transfusion thresholds has been acknowledged within the guidelines and supports the equipoise upon which the Thresholds for Platelets (T4P) trial is based. We await the future findings of this work, which will no doubt be invaluable in informing platelet thresholds in future guidelines. However, in the interim, the anaesthetic and critical care community requires guidance to support clinical decision-making, and our guidelines sought to advise the community based on knowledge and expertise that is currently available.
The use of viscoelastic testing has been well documented in cardiac surgery, liver transplant surgery and trauma [3]. Although there is no robust evidence for its use in central venous catheter insertion, it remains theoretically valid that it can provide valuable information regarding clot formation and strength. For example, the critical care population is highly heterogeneous, and coagulation abnormalities are common and varied [4]. The functional assessment of coagulation provided by viscoelastic testing is likely to be informative as well as a step towards the personalised care that these patients require. We recognise the use of viscoelastic testing in central venous catheter insertion as an area for further research and strongly encourage studies in this area. There is also a need to develop standardised protocols to guide use and interpretation due to a lack of familiarity with the technology and its output together with cost and resource constraints [5].
We reiterate that the updated safe vascular access guidelines are based on current available evidence, and we welcome initiatives such as the T4P trial which aims to provide the community with a strong evidence base to inform future guidelines.
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