Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device (CMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: at 2 hours
次要结局
- Time needed by the nursing staff to set up the system(at 2 hours)
- Evaluation of missing data due to device malfunction(at 2 hours)
- Nurse satisfaction (System Usability Scale)(at 2 hours)
- Occurrence of events during the course of the study(at 2 hours)