Assessing Innovative Wireless and Wearable Sensors for Continuous Blood Pressure Measurement in Obese and Super-obese Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line
研究概览
简要总结
This study is a prospective study targeting at least 20 obese and super-obese patients admitted to Labor & Delivery (L&D) for delivery at UNC Medical Center. Patients with clinical indicated radial A-lines either planned or already in-situ will be offered participation. The study will evaluate the accuracy of noninvasive blood pressure measurements with the ANNE One system to blood pressure readings with the radial A-line.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old
- •Ability and willingness to provide written informed consent
- •Admitted for delivery at UNC Medical Center
- •BMI of >= 40 kg/m2
- •Clinically indicated radial A-lines either planned or already in-situ prior to delivery
排除标准
- •Skin sensitivity or allergy that precludes placement of ANNE One
- •Any condition (social or medical) which, in the opinion of the study staff would make any study participation unsafe or complicate data interpretation
- •Expected delivery within <= 1 hour of arrival to L&D
结局指标
主要结局
Mean absolute error (MAE) and standard deviation of blood pressure measurements with ANNE One compared to arterial line
时间窗: 8 hours
Mean absolute error and standard deviation between the non-invasive blood pressure measurement provided by the device under test and the invasive blood pressure measurement from the arterial line.
次要结局
未报告次要终点