Szrama Jakub, Gradys Agata, Woźniak Amadeusz, Nowak Zuzanna, Bartkowiak Tomasz, Lohani Ashish, Zwoliński Krzysztof, Koszel Tomasz, Kusza Krzysztof
Department of Anesthesiology, Intensive Therapy and Pain Management, Poznan University of Medical Sciences, 60-355 Poznan, Poland.
Life (Basel). 2025 Mar 4;15(3):400. doi: 10.3390/life15030400.
Microvascular free flap surgery is a treatment method for patients with head and neck cancer requiring reconstruction surgery. Patients undergoing this complex, long-lasting surgery are prone to prolonged episodes of intraoperative hypotension, which is associated with increased incidence of postoperative mortality, morbidity, and free flap failure. A new technology recently approved, named the Hypotension Prediction Index (HPI), allows precise hemodynamic monitoring of patients under general anesthesia, with a significant reduction of intraoperative hypotension events. This study aims to assess the impact of the Hypotension Prediction Index (HPI) on the incidence and severity of intraoperative hypotension in patients undergoing free flap surgery.
Eligible patients will be randomly assigned to one of two groups: Group A, receiving invasive blood pressure monitoring with standard medical therapy, or Group B, undergoing hemodynamic monitoring using the Hypotension Prediction Index (HPI) software. The primary outcome is the time-weighted average (TWA) of mean arterial pressure (MAP) < 65 mmHg. Secondary outcomes include free flap viability and perioperative complications.
Ethics approval was obtained from the Poznan University of Medical Sciences Ethics Committee (KB-560/22; date 1 July 2022). Results will be submitted for publication in a peer-reviewed journal.
NCT05738603.
微血管游离皮瓣手术是头颈部癌症患者进行重建手术的一种治疗方法。接受这种复杂、耗时手术的患者容易出现术中低血压时间延长的情况，这与术后死亡率、发病率及游离皮瓣失败的发生率增加有关。最近获批的一项名为低血压预测指数（HPI）的新技术能够在全身麻醉下对患者进行精确的血流动力学监测，显著减少术中低血压事件。本研究旨在评估低血压预测指数（HPI）对接受游离皮瓣手术患者术中低血压的发生率及严重程度的影响。
符合条件的患者将被随机分为两组：A组接受有标准药物治疗的有创血压监测，或B组使用低血压预测指数（HPI）软件进行血流动力学监测。主要结局是平均动脉压（MAP）<65 mmHg的时间加权平均值（TWA）。次要结局包括游离皮瓣存活情况及围手术期并发症。
已获得波兹南医科大学伦理委员会的伦理批准（KB-560/22；日期为2022年7月1日）。研究结果将提交至同行评审期刊发表。
NCT05738603。
