Evaluation of a Novel, Image-Guided Robotic Intubation Platform for Difficult Airways: A Prospective Observational Study

摘要

Safe and successful management of difficult tracheal intubations (DTIs) remains a significant challenge due to anatomical variability, patient comorbidities, and operator-dependent factors. While video laryngoscopy (VL) has improved first-attempt success rates, failures still occur in 11% to 45% of cases,1–4 with ultimate failure rates between 5.2% and 7.3%.5 The primary aim of this prospective observational study was to evaluate efficacy of the use of a novel, handheld, image-guided robotic intubation system Spiro-VISTA (Spiro Robotics, Inc) designed to enhance precision, control and procedural success in patients with difficult airways. METHODS The trial was conducted at Kaunas Hospital of the Lithuanian University of Health Sciences from October to November 2024, with written informed consent obtained from all patients. The study was approved by the local Institutional Ethics Committee and the Lithuanian Ministry of Health, was prospectively registered with the European Database on Medical Devices (EUDAMED, registration number CIV-LT-24-08-048614), and adhered to Good Clinical Practice (GCP) and STROBE guidelines (https://www.strobe-statement.org). The trial included 30 adult patients (ASA physical status 1-3) with anticipated difficult airways presenting for elective surgery. The inclusion criteria required at least one predictor of difficult direct or video laryngoscopy based on standard airway assessment tests, a history of difficult intubation, BMI ≥ 35 kg/m², large neck circumference (NC), or specific independent predictors of difficult VL, including head and neck cancer diagnosis, neck pathology (a mass, a scar, radiation changes), short thyromental (TMD) distance, NC:TMD ratio of ≥ 5, a simplified Arné score ≥ 11 (Supplemental Digital Content, Table S1, https://links.lww.com/AA/F399), and others.1,2,6–9 Awake intubation was performed at the operator’s discretion; such patients, and those with advanced cardiovascular or pulmonary disease, were excluded. The anesthetic protocol and study procedures were standardized for all patients. All patients were orotracheally intubated by study investigators (A.K., D.B., J.B., and L.K.) using Spiro-VISTA™ (Video Intubation System for Total Access), which integrates dual VL and video bronchoscopy guidance with the joystick-controlled, precision robotic (servo-operated) intubation interface (Figure and Video 1). {"href":"Single Video Player","role":"media-player-id","content-type":"play-in-place","position":"float","orientation":"portrait","label":"Video 1","caption":"","object-id":[{"pub-id-type":"doi","id":""},{"pub-id-type":"other","content-type":"media-stream-id","id":"1_aq8i5d3r"},{"pub-id-type":"other","content-type":"media-source","id":"Kaltura"}]} Figure.: Spiro-VISTA essential components, controls and assembly. Spiro-VISTA is an investigational airway device not yet cleared or approved for commercial use by the FDA or other regulatory bodies. Spiro-VISTA™ integrates video laryngoscopy (VL) and a robotic (servo-operated), disposable flexible intubation scope (FIS), controlled by an operator using a joystick and buttons embedded in a specialized 2-channel disposable endoscopy blade. The system currently supports standard endotracheal tubes (ETT) from 5.0 to 7.5 mm ID. Fully assembled spiro-VISTA (A) and its key components (A and B): 1—A reusable handheld unit with integrated VL baton and servo controls. 2—A reusable video cable connecting Spiro-VISTA to Spiro’s split-screen monitor (not shown). 3—A disposable, robotic FIS that attaches to the servo control section of the handheld unit. 4—A 2-channel disposable blade with manual FIS controls (highlighted in blue circle), including a joystick and advancement buttons. When the blade is attached, its controls automatically interface with the servo control section of the handheld unit. 5—A standard endotracheal tube (ETT) preloaded over FIS and positioned within the right channel of the blade. The left channel accommodates the VL