Clinical Evaluation of the Vital Signs Monitoring System (VSMS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- .ECG signal recording and Respiration measured in units heart beat per minute
研究概览
简要总结
This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.
详细描述
This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group.
The primary objectives of the study are:
- Evaluate the body temperature measured by the ear unit and validate its accuracy.
- Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor.
- Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads.
The secondary objectives of the study are: 4. Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements). 5. Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest.
The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed written informed consent
- •Age above 18 years from both genders
- •American Society of Anesthesiologists (ASA) physical status classification of 1-4
- •Hospitalized in internal ward
排除标准
- •Abuse of alcohol or illicit drugs
- •History of mental retardation or any mental disease
- •Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
结局指标
主要结局
.ECG signal recording and Respiration measured in units heart beat per minute
时间窗: 6-10 days
Assess quality of device's recorded ECG and respiration signals as compared to patient monitor with standard leads
Skin Temperature measured in units of Celsius/Fahrenheit
时间窗: 6-10 days
Validation of measurement accuracy of skin temperature as compared to gold standard.
Oxygen Saturation measured in units of percentage peripheral saturated oxygen
时间窗: 6-10 days
Validation of measurement accuracy of peripheral oxygen saturation as compared to gold standard.
次要结局
- Quality of recorded signal(after 5-7 days of device usage)