Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model CVSM-1A) for Clinical Use and Self Measurement in Ambulatory Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pulse Rate
研究概览
简要总结
The VERDICT-2 verification study will examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants. The objective is to determine the accuracy of continuous non-invasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and cNIBP against standard comparator devices guided by consensus standards.
详细描述
Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved.
The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography [PPG]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques.
The VERDICT-2 verification study will examine the accuracy of the Vitaliti CVSM in an ambulatory context with healthy participants.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Healthy participant (no known significant health problems)
- •Provide informed consent to participate
排除标准
- •Active smoker
- •Recent exposure to carbon monoxide
- •Have unexplained shortness of breath at rest
- •Hearing aid/Cochlear Implant
- •Current arrhythmia
- •ICD/Pacemaker
- •Current respiratory disease/infection
- •Significant body tremors/shaking
- •History of unexplained fainting/syncope
- •Have any disorder that prohibits placement of the device (i.e., skin rash/abrasion, open or infected sore)
- •Cerebrospinal Fluid Shunt
- •Unable to ambulate, stand, or lay in supine position
- •Allergy to adhesive
- •Unable to understand or speak English
结局指标
主要结局
Pulse Rate
时间窗: 27 Minutes
Determining the accuracy of the ECG/photoplethysmography (PPG) on the Vitaliti device to measure pulse rate, compared to an appropriate standardized comparator device. Detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in IEC 60601-2-27:2011/ (R2016).
Oxyhemoglobin Saturation
时间窗: 27 Minutes
Determining the accuracy of the electrocardiogram (ECG)/photoplethysmography (PPG) on the Vitaliti device to measure blood oxygen saturation, compared to an appropriate standardized comparator device. A detailed analysis will be performed to compare the Vitaliti device against performance criteria as defined in ISO 80601-2-61:2017, MOD.
Heart Rate
时间窗: 36 Minutes
Determining the accuracy of the electrocardiogram (ECG) on the Vitaliti device to measure heart rate, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in IEC 60601-2-27:2011/ (R2016).
Blood Pressure
时间窗: 30 Minutes
Determining the accuracy of the electrocardiogram (ECG)/photoplethysmography (PPG) on the Vitaliti device to measure blood pressure, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy against performance criteria as defined in ISO 81060-2: 2018/AMD-1:2020.
Respiration Rate
时间窗: 44 Minutes
Determining the accuracy of the impedance respiration waveform on the Vitaliti device to measure respiration rate, compared to an appropriate standardized comparator device. The Vitaliti CVSM will be evaluated against performance criteria determined to be clinically relevant, in alignment with predicate devices, and as defined by the manufacturer, since there are no internationally recognized consensus standards.
Temperature
时间窗: 12 Minutes
Determining the accuracy of the infrared sensor on the Vitaliti device to measure core body temperature, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in ISO 80601-2-56:2017/AMD-1:2018.
次要结局
未报告次要终点