Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Blood Pressure Comparison
研究概览
简要总结
This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the CareTaker PDA device placed on their finger during their operation to collect data for 30 minutes. Blood pressure readings from the CareTaker PDA device will be compared to measurements from the patient's indwelling arterial line, which will be placed as part of the patient's clinical care plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus
排除标准
- •Patients with vascular or congenital heart disease known to affect large and small arteries
- •Patients who declined to participate.
研究组 & 干预措施
All Enrolled Patients
Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.
干预措施: CareTaker PDA Device (Device)
结局指标
主要结局
Blood Pressure Comparison
时间窗: One hour during procedure
The accuracy of blood pressure measurements taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Blood Pressure Comparison (Systolic)
时间窗: One hour during procedure
The accuracy of blood pressure measurements (systolic) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Blood Pressure Comparison (Diastolic)
时间窗: One hour during procedure
The accuracy of blood pressure measurements (diastolic) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
Blood Pressure Comparison (Mean)
时间窗: One hour during procedure
The accuracy of blood pressure measurements (mean) taken from the non-invasive blood pressure device will be compared to measurements taken from the patient's indwelling arterial line, which will be place as part of standard of care.
次要结局
未报告次要终点
研究者
Karen Boretsky
Anesthesiologist
Boston Children's Hospital