Szrama Jakub, Gradys Agata, Nowak Zuzanna, Lohani Ashish, Zwoliński Krzysztof, Bartkowiak Tomasz, Woźniak Amadeusz, Koszel Tomasz, Kusza Krzysztof
Department of Anesthesiology, Intensive Therapy and Pain Management, Poznan University of Medical Sciences, 60-355, Poznan, Poland.
Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb.
Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.
: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of <65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.
This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB-559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.
NCT06247384.
接受大型腹部手术的患者发生围手术期低血压的风险增加，这与死亡率和发病率的上升相关。尽管使用了诸如评估动脉压衍生心输出量等先进技术，但在低血压发生后做出临床决策时，维持血流动力学稳定的麻醉管理仍然是被动的。以往的围手术期目标导向研究尚未高度确定性地证明这种方法的益处。一种名为低血压预测指数（HPI）的新的获批技术旨在通过对全身麻醉患者进行精确的血流动力学监测来预防低血压的发生，显著减少术中低血压事件。这项前瞻性随机临床试验旨在根据血流动力学监测类型比较接受大型腹部手术患者的围手术期低血压发生率。
符合纳入标准的患者将被随机分配接受动脉压心输出量（APCO）监测的血流动力学评估（A组）或使用HPI软件进行血流动力学监测（B组）。主要结局是时间加权平均（TWA）平均动脉压（MAP）<65 mmHg：TWA MAP =（低于65 mmHg的MAP时的低血压深度[以mmHg为单位]×低于65 mmHg的MAP所花费的时间[以分钟为单位]）/手术总时长（以分钟为单位）。其次要结局包括围手术期血流动力学管理和术后并发症发生率。
本试验经波兹南医科大学伦理委员会批准（KB-559/220；日期：2022年7月1日）。其结果将提交至同行评审期刊发表。
NCT06247384。
