Accuracy of the NICCI™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Difference in Blood Pressure
研究概览
简要总结
This is a prospective study that will compare the blood pressure readings from an arterial cannula with those obtained non-invasively by the NICCI device. The study will enroll 50 patients into each of three weight ranges: 10-20 kg, 20-40 kg, and 40-80 kg.
The NICCI, Pulsion/GETINGE uses novel technology to provide a continuous estimation of BP displayed as a waveform similar to that seen with an invasive arterial cannula, but is totally non-invasive by using the fingers. The patient rests their hand on the device, which is about the size of a computer mouse, and then a blood pressure cuff goes around their upper arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring anesthetic care and in whom an indwelling arterial cannula will be placed for the surgical procedure.
排除标准
- •Patients with history of a peripheral neurologic or neuropathic disorder
- •Patients in whom the upper extremity cannot be used for blood pressure monitoring
- •Patients in whom an invasive arterial cannula cannot be placed
- •Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
- •Edematous patients
结局指标
主要结局
Difference in Blood Pressure
时间窗: 2-8 hours (average length of major surgery)
The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg.
次要结局
- Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC(2-8 hours (average length of major surgery))
- Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC(2-8 hours (average length of major surgery))
- Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC(2-8 hours (average length of major surgery))
研究者
Joseph D. Tobias
Chief, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital