Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Composite Outcome Measure - Successful Vital Signs Acquisition
研究概览
简要总结
This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.
详细描述
To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.
The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:
- Arterial blood oxygen Saturation (SpO2)
- ECG (up to 3 - Lead)
- Heart Rate (Part of ECG)
- Surface Temperature
- Respiration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Adult male and female hospital in-patients
- •Vital signs considered 'stable' by clinical caregivers
排除标准
- •Pediatric patients
- •Female patients who are pregnant
- •Patients with internal or external defibrillators
- •Patients who have undergone surgery and still have a fresh incision on the chest
- •Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
- •Patients who are in the Critical Care Unit (CCU)
- •Patients who otherwise satisfy any of the contraindications associated with the VSP system.
结局指标
主要结局
Composite Outcome Measure - Successful Vital Signs Acquisition
时间窗: Up to Four Days
Successful acquisition of Temperature, Heart Rate, ECG, Respiration, SpO2 daily for the inpatient stay of the subject up to four days. Success is achieved if all vital signs are obtained on a study participant. It is a composite result.
次要结局
- Adhesion(Up to Four Days)