Abstract
INTRODUCTION: Difficult tracheal intubation remains a critical issue in airway management. While videolaryngoscopy (VL), particularly using hyperangulated blades such as the C-MAC D-Blade, has become the gold standard due to superior glottic visualization compared to direct laryngoscopy (DL), intubation challenges persist. The ProVu™ Video Stylet (PVS) is a novel device that integrates real-time visualization with a guided endotracheal tube system. METHODS: This is an open-label, randomized, three-arm parallel-group, we evaluated whether the use of PVS in combination with either DL or VL could improve tracheal intubation outcomes in anesthetized patients with anticipated difficult airways, defined by an Arné score ≥ 11. The primary outcome was first-pass intubation success. Secondary outcomes included laryngoscopy and intubation times, number of attempts, need for external airway manipulation, and complications related to difficult intubation. RESULTS: One hundred fourteen patients undergoing elective surgery were randomized into three groups: VL using C-MAC D-Blade alone, PVS with DL, and PVS with VL. First-pass intubation success was significantly higher in both PVS-assisted groups compared to the VL-only group (100% vs. 86.8%, P = 0.04). Median intubation times were also shorter in the PVS groups (32.7 and 32.0 s) compared to the control group (38.9 s). No episodes of oxygen desaturation below 90%, need for rescue techniques, or severe complications were observed. Principally, minor complications were observed only in the videolaryngoscope-alone group. CONCLUSION: The integration of the ProVu™ with either direct or video laryngoscopy significantly improves first-attempt intubation success and reduces intubation time compared to videolaryngoscopy alone in patients with anticipated difficult airways. TRIAL REGISTRATION: Registered in ClinicalTrials.gov (NCT05902858) on 23th january 2023. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12871-026-03754-7.