Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Posture
研究概览
简要总结
This study has the following objective:
• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
详细描述
This study has the following objective:
• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 21 years of age or older.
- •Subject is willing and able to sign the Informed Consent Form.
- •Subject is healthy, able and willing to complete all the preparation steps and study procedures.
- •Exclusion Criteria
- •Female subject with a known pregnancy or unsure about pregnancy status.
- •Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- •Subjects with skin breakdown in areas where device placement is required.
- •Subjects with chronic lung disease or asthma.
- •Subjects with a history of cardiovascular diseases.
- •Subjects who are diabetic.
- •Subjects living with kidney failure or dialysis.
- •Subjects with a history of liver failure.
- •Subjects with any known malignancy (i.e. cancer patients).
- •Subjects with implanted devices in the thoracic region
排除标准
- 未提供
结局指标
主要结局
Posture
时间窗: Immediately
90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position
Heart Rate
时间窗: Immediately
Respiratory rate
时间窗: Immediately
The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).
Activity
时间窗: Immediately
μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.
ECG
时间窗: Immediately
次要结局
未报告次要终点