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Validation of a Connected Patch, an Alternative to Conventional Monitoring

2020年2月3日 更新者:Hopital Foch
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

研究概览

地位

撤销

条件

详细说明

When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.

The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.

One of the crucial issues is therefore the speed of the alarm and its reliability.

The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.

The connected patch used in this research is the Scaléo Médical company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.

The objective of this research is therefore to validate Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.

研究类型

介入性

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Suresnes、法国、92150
        • Hôpital Foch

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • patient over 18 and under 85 years of age
  • patient requiring general anesthesia for extra-thoracic surgery
  • the patient's position during the operation is in supine position only
  • patient affiliated to or benefiting from social security, excluding State Medical Assistance
  • patient with written consent

Exclusion Criteria:

  • pregnant or breastfeeding patients
  • patients known to have severe skin reactions to adhésives
  • patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
  • patients deprived of their liberty or under guardianship

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:连接补丁验证
使用连接贴片采集血压、​​心率、呼吸率、动脉血氧饱和度和体温

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Concordance of blood pressure value measured by 2 different devices after surgery
大体时间:36 hours maximum after the surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of heart rate value measured by 2 different devices after surgery
大体时间:36 hours maximum after the surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of respiratory rate value measured by 2 different devices after surgery
大体时间:36 hours maximum after the surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
大体时间:36 hours maximum after the surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of temperature value measured by 2 different devices after surgery
大体时间:36 hours maximum after the surgery
Comparison between temperature measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery

次要结果测量

结果测量
措施说明
大体时间
Concordance of blood pressure value measured by 2 different devices during surgery
大体时间:During surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of heart rate value measured by 2 different devices during surgery
大体时间:During surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of respiratory rate value measured by 2 different devices during surgery
大体时间:During surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of arterial oxygen saturation value measured by 2 different devices during surgery
大体时间:During surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of temperature value measured by 2 different devices during surgery
大体时间:During surgery
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
During surgery
Blood pressure artifact
大体时间:From surgery to 36 hours maximum after the surgery
Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
From surgery to 36 hours maximum after the surgery
Heart rate artifact
大体时间:From surgery to 36 hours maximum after the surgery
Value of heart rate will be considered as artifact if value < 40 or > 140
From surgery to 36 hours maximum after the surgery
Respiratory rate artifact
大体时间:From surgery to 36 hours maximum after the surgery
Value of respiratory rate will be considered as artifact if value < 8 or > 36
From surgery to 36 hours maximum after the surgery
Arterial oxygen saturation artifact
大体时间:From surgery to 36 hours maximum after the surgery
Value of arterial oxygen saturation will be considered as artifact if value < 85 %
From surgery to 36 hours maximum after the surgery
Acceptability of connected patch: numerical scale
大体时间:During the surgery and through study completion
Evaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
During the surgery and through study completion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Morgan Le Guen、Hôpital Foch

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年1月1日

初级完成 (预期的)

2020年9月4日

研究完成 (预期的)

2020年9月4日

研究注册日期

首次提交

2019年8月6日

首先提交符合 QC 标准的

2019年8月9日

首次发布 (实际的)

2019年8月12日

研究记录更新

最后更新发布 (实际的)

2020年2月5日

上次提交的符合 QC 标准的更新

2020年2月3日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2017055F

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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