Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Non-invasive Blood Pressure Monitor (NIPB) Measurements
研究概览
简要总结
Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- •Participant weighs ≥ 34kg.
- •Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.
排除标准
- •Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
- •The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
研究组 & 干预措施
Non-Invasive Blood Pressure (NIPB)Monitors
NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis.
VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis.
干预措施: Intermittent Non-InvasiveBlood Pressure Monitor (Device)
结局指标
主要结局
Non-invasive Blood Pressure Monitor (NIPB) Measurements
时间窗: 7 days from start of participation
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.
次要结局
- Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)(7 days from start of participation)
- Intradialytic Blood Pressure Events(7 days from start of participation)