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临床试验/NCT07405892
NCT07405892尚未招募不适用

The Impact of Hypotension Prediction Index-Guided Management on Intraoperative Hypotension and Major Postoperative Complications in Patients Undergoing Oral Cancer Resection and Reconstruction

National Taiwan University Hospital0 个研究点目标入组 100 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
time weight average mean arterial pressure less than 65 mmHg

研究概览

简要总结

Investigating HPI effect in oral cancer surgery

详细描述

Intraoperative hypotension, defined as a mean arterial pressure (MAP) below 65 mmHg, is common during oral cancer resection with reconstruction-a lengthy procedure averaging 13 hours. Prolonged anesthesia increases the risk of intraoperative hypotension, which would lead to a higher need for vasopressor administration and fluid transfusion. Additionally, surgical anastomosis sites are vulnerable, and hypotension has been linked to increased risks of anastomotic necrosis, septic shock, organ failure, and mortality.

The Hypotension Prediction Index (HPI) is a machine-learning-based algorithm introduced in 2019 that analyzes arterial pressure waveform characteristics to provide real-time monitoring and early prediction of hypotensive episodes-defined as a MAP <65 mmHg lasting for at least one minute-during surgery. Recent randomized controlled trials have evaluated the effectiveness of HPI-guided management in preventing intraoperative hypotension. These studies commonly use the "time-weighted average (TWA) MAP <65 mmHg" as the primary outcome, calculated as the area under the threshold (in mmHg×hours) divided by the total duration of surgery (in hours). The lower the value, the shorter and less severe the intraoperative hypotension. However, limited studies have specifically investigated the impact of HPI-guided management on the duration and severity of intraoperative hypotension and postoperative complications in patients undergoing oral cancer resection with reconstruction.This study aims to evaluate the effectiveness of HPI-guided management in reducing the duration and severity of intraoperative hypotension in patients undergoing oral cancer resection with free flap reconstruction. The investigator hypothesize that the TWA-MAP <65 mmHg will be significantly lower in the HPI-guided group compared to the standard care group. Postoperative major complications will be followed during postoperative 30 days. One hundred patients aged 20 to 80 years undergoing elective oral cancer resection with free flap reconstruction will be randomized to receive hemodynamic management with or without HPI guidance. Clinicians caring for patients assigned to the HPI guidance group will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation. Primary outcome is the data of TWA-MAP<65mmHg. Postoperative complications and mortality will be followed up to postoperative 30 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patients were blinded to their group allocation, and outcome assessors were also blinded.

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective oral cancer surgery with free flap reconstruction

排除标准

  • severe arrhythmia

研究组 & 干预措施

HPI silence

Active Comparator

HPI silence

干预措施: HPI silence (Device)

HPI

Experimental

HPI guidance

干预措施: HPI (Device)

结局指标

主要结局

time weight average mean arterial pressure less than 65 mmHg

时间窗: the duration of surgery

a value indicating the severity and duration of intraoperative hypotension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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