Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD) (SMART-METRO)
Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
Complications due to the medical practice are the third cause of morbidity(BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.
Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Créteil、法国、94 010
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
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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:
- Age ≥ 18 years
- Patients receiving a non-ambulatory surgical or interventional procedure lasting more than 2 hours
- Affiliation with a social security syste, beneficiarie or eligible people (excluding State Medical Assistance (AME))
- Written consent of the patient
Exclusion Criteria:
- Patient carrying a multi-resistant germ and placed in isolation
- Patient's known linguistic inability to understand the study
- Non-ambulatory surgical or interventional act in an emergency situation
- Patients under legal protection : curatorship or guardianship
- Known pregnancy or nursing woman
- Patients with implantable cardiac pacemakers, implantable defibrillators or neurostimulators
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Connected Medical Device
"SMART ANGEL Intra-hospital" System 's Connected Medical Device (DMC) measuring physiological parameters in the operating room
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Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
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有源比较器：Traditional system
Traditional wired transmission system between the sensor and the data processing device in the operating room
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Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Agreement between the values measurements produced by the traditional monitoring system in the operating theater and the connected medical device of the "SMART ANGEL intra-hospital" system
大体时间：at 2 hours
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at 2 hours
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Evaluation of missing data due to device malfunction
大体时间：at 2 hours
|
at 2 hours
|
|
Nurse satisfaction (System Usability Scale)
大体时间：at 2 hours
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at 2 hours
|
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Occurrence of events during the course of the study
大体时间：at 2 hours
|
at 2 hours
|
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Time needed by the nursing staff to set up the system
大体时间：at 2 hours
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at 2 hours
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合作者和调查者
调查人员
- 首席研究员：Jean-Louis MARTY, MD, PhD、Assistance Publique - Hôpitaux de Paris
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
- APHP190708
- 2019-A02197-50 (其他标识符：N° IDRCB)
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
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