B40 Non-Invasive Blood Pressure Equivalency Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Colorado
-
Louisville、Colorado、美国、80027
- Clinimark
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Blood Pressure Reading
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
|
Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
大体时间：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.
|
End of each blood pressure reading
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.