Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
研究概览
简要总结
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.
详细描述
Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All Groups:
- •Able to provide informed consent
- •Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
- •18 years of age, or older
- •Normotensive:
- •1. Systolic blood pressure <140 mmHg (18,66 kPa) and diastolic blood pressure <90 mmHg (12 kPa)
- •Hypertensive:
- •Without proteinuria >300 mg in 24 h; and
- •With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)
- •Pre-Eclampsia:
- •With proteinuria >300 mg in 24 h; and
- •With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
排除标准
- 未提供
研究组 & 干预措施
Normotensive
Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
干预措施: Blood pressure measurement (Device)
Hypertensive
Hypertensive pregnant patients beyond the first trimester:
i) without proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg
干预措施: Blood pressure measurement (Device)
Pre-Eclampsia
Pre-eclampsia patients beyond the first trimester:
i) with proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg
干预措施: Blood pressure measurement (Device)
结局指标
主要结局
Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
时间窗: Up to 60 minutes
Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.
次要结局
未报告次要终点
研究者
Robin Driver
Principal Investigator
Mount Carmel Health System