B40 Non-Invasive Blood Pressure Equivalency Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
研究概览
简要总结
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
详细描述
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- •Within the age range from older than 3 years old to 75 years old (adult and child)
- •Ability to maintain proper placement of cuff and/or probe and/or sensor
排除标准
- •Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
- •Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- •Known dysrhythmias (when applicable)
- •Known disease state that compromises circulation to the extremity
- •Vigorous exercise prior to participating in the study
- •Excessive movement or excitability causing false values or no determinations
- •Known allergy to latex when latex products will be in contact with subject
- •Pregnant females
结局指标
主要结局
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
时间窗: End of each blood pressure reading
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
次要结局
未报告次要终点