A prospective, post market, non-interventional observational, open label, single arm, single center study to confirm the clinical safety and performance of Skanray’s Patient Monitors
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Continuous monitoring of vital physiological parameters such as ECG 3 5 12 lead, arrhythmia & ST analysis, respiration rate, non invasive blood pressure, invasive blood pressure, temperature, SpO2, end tidal CO2, cardiac output, non-invasive cardiac output and anesthesia gas monitoring.
研究概览
简要总结
Skanray’s Patient monitoring system are multi-parameter semi-modular patient monitoring system for continuous monitoring of the physiological parameters such as electrocardiogram, ST analysis, Respiration rate, Temperature, Non invasive blood pressure, Oxygen saturation (SpO2), Invasive blood pressure, End tidal carbon dioxide, Cardiac output, Non invasive cardiac output & Anesthesia gas monitoring. The purpose of this study is to confirm the clinical safety and performance of Skanray’s Patient monitoring systems. This study will generate the clinical evidence to support the claimed intended use.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult, pediatric and neonatal subjects of either genders.
- •The patients who need continuous physiological parameters monitoring in different areas of the hospital (Ex; ICU, OT, emergency, wards, operative care etc.) The subjects or the legally authorised representative capable of understanding and signing the informed consent.
排除标准
- •Subjects who are to be monitored in an MRI environment or in an oxygen-enriched environment.
- •Neonates shall be excluded for ST segment and arrhythmia analysis.
结局指标
主要结局
Continuous monitoring of vital physiological parameters such as ECG 3 5 12 lead, arrhythmia & ST analysis, respiration rate, non invasive blood pressure, invasive blood pressure, temperature, SpO2, end tidal CO2, cardiac output, non-invasive cardiac output and anesthesia gas monitoring.
时间窗: Every 1 hours
次要结局
- Collection of feedback reflecting the usability and design features from users.(Collection of evidence reflecting the monitored parameters.)