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临床试验/NCT04736862
NCT04736862已完成不适用

The Impact of Continuous Non-invasive Blood Pressure Monitoring on Post-induction and Intraoperative Hypotension in Patients Having Non-cardiac Surgery (DETECT Trial): A Randomized Trial

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2021年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
242
试验地点
2
主要终点
Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.

研究概览

简要总结

This is a randomized trial (1) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery; and (2) investigating whether continuous non-invasive finger-cuff blood pressure monitoring reduces the time-weighted average for MAP <65 mmHg during the intraoperative period compared to intermittent blood pressure monitoring using upper-arm cuff oscillometry in patients having non-cardiac surgery.

详细描述

not provided

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
Single (Care Provider)

入排标准

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

入选标准

  • Patients at least 45 years of age scheduled for elective non-cardiac surgery with general anesthesia are eligible for study inclusion if blood pressure monitoring using intermittent upper-arm cuff oscillometry is planned.

排除标准

  • Emergency surgery,
  • pregnancy,
  • American Society of Anesthesiologists (ASA) physical status classification V or VI, blood pressure differences between the right and left arm of more than 20 mmHg, intraoperative invasive blood pressure monitoring, heart rhythms other than sinus rhythm.

研究组 & 干预措施

Continuous monitoring group

Experimental

干预措施: Continuous non-invasive blood pressure monitoring (Device)

Intermittent monitoring group

Active Comparator

干预措施: Intermittent non-invasive blood pressure monitoring (Device)

结局指标

主要结局

Area under a MAP of 65 mmHg within the first 15 minutes of anesthetic induction between the intervention and the control group.

时间窗: 15 min

Time-weighted average for MAP <65 mmHg during the intraoperative period between the intervention and the control group.

时间窗: intraoperative

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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