Validation of a Connected Patch, an Alternative to Conventional Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Hopital Foch
- 试验地点
- 2
- 主要终点
- Concordance of heart rate value measured by 2 different devices after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Concordance of heart rate value measured by 2 different devices after surgery
时间窗: 36 hours maximum after the surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
时间窗: 36 hours maximum after the surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
Concordance of temperature value measured by 2 different devices after surgery
时间窗: 36 hours maximum after the surgery
Comparison between temperature measured by conventional medical monitoring device and by connected patch
Concordance of blood pressure value measured by 2 different devices after surgery
时间窗: 36 hours maximum after the surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
Concordance of respiratory rate value measured by 2 different devices after surgery
时间窗: 36 hours maximum after the surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
次要结局
- Concordance of arterial oxygen saturation value measured by 2 different devices during surgery(During surgery)
- Concordance of temperature value measured by 2 different devices during surgery(During surgery)
- Concordance of heart rate value measured by 2 different devices during surgery(During surgery)
- Concordance of respiratory rate value measured by 2 different devices during surgery(During surgery)
- Blood pressure artifact(From surgery to 36 hours maximum after the surgery)
- Heart rate artifact(From surgery to 36 hours maximum after the surgery)
- Respiratory rate artifact(From surgery to 36 hours maximum after the surgery)
- Arterial oxygen saturation artifact(From surgery to 36 hours maximum after the surgery)
- Acceptability of connected patch: numerical scale(During the surgery and through study completion)
- Concordance of blood pressure value measured by 2 different devices during surgery(During surgery)