A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Clinician assessment of 12-lead ECG reports
研究概览
简要总结
A multicenter, prospective and retrospective, observational, post market study.
详细描述
This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)
- •One or more 12-lead ECG recorded
- •Use of 3 or more of the following sensors to measure vital signs
- •NIBP (Non-Invasive Blood Pressure)
- •HR (Heart Rate)
- •SpO2 (Oxygen Saturation)
- •PVI (Pleth Variability Index)
- •SpCO (Carboxyhemoglobin)
- •SpOC (Oxygen Content)
- •SpHb (Total Hemoglobin)
- •SpMet (Methemoglobin Saturation)
- •EtCO2 (End-tidal Carbon Dioxide)
排除标准
- •None defined
研究组 & 干预措施
Standard of Care
Standard of Care for emergency care
干预措施: Standard of Care (Diagnostic Test)
结局指标
主要结局
Clinician assessment of 12-lead ECG reports
时间窗: through study completion, an average of 1 year
The proportion of 12-lead ECG pairs that are identical, after a cardiologist's review of printouts from Corsium IntelliSpace (transmitted) ECG and the original ECG from the Tempus Pro device.
Diagnostic quality of 12-lead
时间窗: through study completion, an average of 1 year
The printed patient record ECG will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality.
Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
时间窗: through study completion, an average of 1 year
The number and proportion of patient vital sign data points, comparing direct data with identical units of measure from printouts from IntelliSpace Corsium (transmitted) vital signs and the original vital signs from the Tempus Pro device.
次要结局
- Number of all activated alarms(through study completion, an average of 1 year)
- IntelliSpace Corsium transmission(through study completion, an average of 1 year)