Provu video stylet-assisted intubation under direct laryngoscopy and video laryngoscopy in high Arne score patients: a randomized clinical trial

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. 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. 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. 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. Registered in ClinicalTrials.gov (NCT05902858) on 23th january 2023.