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临床试验/NCT05297318
NCT05297318已完成不适用

Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Time-weighted average mean arterial pressure less than 65 mmHg

研究概览

简要总结

The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.

详细描述

Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg).

Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.

Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.

Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.

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, Care Provider)

盲法说明

patients and care providers did not know the whether the hypotension prediction index use during the operation.

入排标准

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

入选标准

  • the age of patients>=65 years old
  • patients receivedd major gastrointestinal surgery

排除标准

  • patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis

结局指标

主要结局

Time-weighted average mean arterial pressure less than 65 mmHg

时间窗: preoperative and postoperative 30 days

A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer 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

研究点 (2)

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