ArteVu Blood Pressure Accuracy Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood pressure and heart rate measurement accuracy
研究概览
简要总结
A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.
详细描述
ArteVu is a non-invasive and continuous blood pressure monitor. It detects the arterial pressure waveform with a force sensor that detects the arterial pulsation that produces changes in pressure transmitted through the subcutaneous tissue overlying or adjacent to the digital arteries. The data is transmitted to a parameter module to display noninvasive and continuous blood pressure in a hospital setting. The primary objective of this study is to validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained from an invasive radial arterial line. The secondary objective is to evaluate the effectiveness of utilizing ArteVu for continuous blood pressure measurements. The study population includes 50 patients undergoing surgery who requires general anesthesia and continuous blood pressure measurement with a radial arterial line. Blood pressure values measured from the arterial line will be recorded simultaneously during ArteVu's measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
- •Limb circumference is within 22 cm - 32 cm
- •The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
- •Ease of access to the finger and arm used for ArteVu
- •Able to provide written informed consent for participation in the study
排除标准
- •Pregnant patients
- •Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger or the ipsilateral arm such as impaired skin integrity
- •Operations involving the upper extremities or the blood vessels of the upper extremities
- •Arthritis or severe deformities of the hand and fingers
- •Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
- •History of malignant hyperthermia
- •Raynaud's disease affecting the fingers or hands
- •Topical allergy to Acrylonitrile Butadiene Styrene(ABS), Polycarbonate(PC), or silicone
- •Swelling, edema or lymphedema of the upper extremity
- •Participants with upper extremity occlusive peripheral vascular diseases
- •Inability of the patient to provide written informed consent
结局指标
主要结局
Blood pressure and heart rate measurement accuracy
时间窗: around two hours.
To validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained intra-arterially from an invasive radial arterial line, meeting a bias (as measured by overall mean difference) less than 5 mmHg and a standard deviation less than 8 mmHg for systolic and diastolic blood pressure. This accuracy satisfies the limits established for the validation of automatic blood pressure measurement according to the ANSI/AAMI/ISO 81060-2 standard.
次要结局
未报告次要终点