Artificial intelligence-based predictive hemodynamic monitoring in conjunction with goal-directed therapy reduces duration, frequency, and severity of intraoperative hypotension in major maxillofacial and otolaryngological surgery—a prospective randomized controlled pilot trial

Background Intraoperative hypotension (IOH) during non-cardiac surgery is associated with increased risk of postoperative complications, including acute kidney injury, myocardial injury, stroke, and mortality. Artificial intelligence-based predictive hemodynamic monitoring using the Hypotension Prediction Index (HPI), combined with goal-directed therapy (GDT), has been proposed to reduce IOH. However, its effectiveness in major maxillofacial and otolaryngologic surgery remains unclear. The purpose of the study was to assess whether HPI-guided management or classical GDT reduces IOH compared to standard care in patients undergoing major maxillofacial and otolaryngologic surgery. Methods In this randomized controlled pilot trial at a university hospital, 75 patients were allocated to one of three groups: control ( n = 25), HPI-guided GDT ( n = 25), or classical GDT without HPI ( n = 25). In the control group, the advanced hemodynamic monitoring was blinded to the anesthesiologist. IOH was defined as mean arterial pressure (MAP) < 65 mmHg for > 1 min. Primary endpoints were the number and total duration of IOH episodes. Secondary endpoints included the time-weighted average MAP < 65 mmHg (TWA65) and postoperative complications. Results Seventy-four patients were analyzed. The HPI group showed significantly fewer IOH episodes (median 3.0 vs. 7.0; p = 0.02) and shorter IOH duration (7.0 min vs. 46.0 min; p < 0.01) compared to control. No significant difference was observed between the classical GDT and control groups. Secondary outcomes were comparable across all groups. Conclusions HPI-guided hemodynamic management significantly reduces the frequency and duration of IOH in major head and neck surgery. Larger studies are needed to evaluate effects on clinical outcomes. Trial registration The trial was registered on clinicaltrials.gov (NCT04151264) on 14th October 2019.