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临床试验/NCT06756672
NCT06756672招募中不适用

Hypotension Prediction Index for Prevention of Hypotension and Postoperative Complications During Laparoscopic Surgery for Colorectal Cancer: A Multi-Center Randomized Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
time weighted average mean arterial pressure (TWA MAP) <65 mmHg (unit: mmHg)

研究概览

简要总结

Using the Hypotension Prediction Index in patients undergoing laparoscopic colorectal surgery, including data from National Taiwan University Hospital and Taipei Veterans General Hospital

详细描述

Intraoperative hypotension is a common occurrence during laparoscopic colorectal cancer resection, often attributable to factors such as general anesthesia, the growing population of elderly patients, and the use of pneumoperitoneum during surgery. This condition, defined as a mean arterial pressure (MAP) below 65 mmHg, is linked to major organ complications within 30 days postoperatively. Introduced in 2019, the Hypotension Prediction Index (HPI) is an algorithm designed to predict the onset of intraoperative hypotension. Previous studies have used the time-weighted average MAP below 65 mmHg as a primary endpoint, calculated as the area under the MAP curve <65 mmHg (mmHg × hours) divided by the duration of surgery (hours), with a value ≥0 indicating severity. Higher values reflect more severe hypotension. However, research on the application of HPI in laparoscopic colorectal cancer resection remains limited. This study aims to determine whether the use of HPI can reduce the severity of intraoperative hypotension in patients undergoing laparoscopic colorectal cancer resection and whether it can decrease the incidence of major postoperative organ complications. A total of 120 patients, aged 20-80 years and undergoing elective laparoscopic colorectal cancer resection, will be randomly assigned to two groups: an intervention group guided by HPI and a control group without HPI guidance. In the intervention group, an alert will be triggered when the HPI exceeds 85, indicating a potential MAP drop below 65 mmHg, whereas the control group will initiate hypotension treatment only when MAP falls below 65 mmHg. Both groups will adhere to the same intraoperative hypotension management protocols, including fluid resuscitation, vasopressor administration, and observation. The primary treatment outcome will be the time-weighted average MAP <65 mmHg, and major postoperative organ complications will be monitored for 30 days post-surgery.

研究设计

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

盲法说明

Patients will not know which group they are in, nor will the outcome assessors

入排标准

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

入选标准

  • •patients undergoing elective laparoscopic colorectal surgery

排除标准

  • •Severe heart or lung diseases

研究组 & 干预措施

HPI guidance

Experimental

patients with HPI guidance

干预措施: HPI guidance (Device)

patients in the control group

Active Comparator

patients without HPI guidance

干预措施: No HPI guidance (Device)

结局指标

主要结局

time weighted average mean arterial pressure (TWA MAP) <65 mmHg (unit: mmHg)

时间窗: during the whole surgery

the severity and duration of 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

研究点 (1)

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HPI in Laparoscopic Colorectal Surgery | 临床试验