Validation of a Connected Patch, an Alternative to Conventional Monitoring
研究概览
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
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Suresnes、法国、92150
- Hôpital Foch
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
赞助
调查人员
- 首席研究员:Morgan Le Guen、Hôpital Foch
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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