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临床试验/NCT07052123
NCT07052123招募中不适用

Non-Invasive Blood Pressure Monitoring in ICU Patients Using the DARE Device

Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2
试验地点
1
主要终点
Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.

研究概览

简要总结

This study tests a new non-invasive device called DARE to monitor blood pressure in patients in intensive care. It compares the device's readings to standard invasive methods and also looks at how well it measures other vital signs like temperature, oxygen levels, and heart rhythm. The goal is to improve patient safety and comfort while helping doctors detect problems earlier.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

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

入选标准

  • Adult patients (male or female), aged 18 years or older
  • Admitted to intensive care unit (ICU) or critical care with an expected hospital stay longer than 2 days
  • Equipped with an arterial catheter for invasive blood pressure monitoring
  • Equipped with a urinary catheter for invasive core body temperature monitoring

排除标准

  • Patients under 18 years old (minors)
  • Known skin allergy to adhesives or silicone, or skin condition preventing adhesive use
  • History of extensive skin pathology (e.g., Lyell syndrome)
  • Patients with therapeutic limitations
  • Patients with active implanted medical devices (e.g., pacemaker, defibrillator)
  • Pregnant or breastfeeding women
  • Patients not affiliated with the French social security system
  • Patients or their legal representatives refusing consent, or unable to understand information and give informed consent
  • Patients under legal guardianship, curatorship, or deprived of liberty

结局指标

主要结局

Primary outcome: Agreement between non-invasive blood pressure index (IPA) from MultiSense® and invasive blood pressure (PAI) from ICU monitors.

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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