NCT00443001已完成不适用
Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards
研究概览
简要总结
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed informed consent
- •a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
- •ability to monitor ECG, NIBP and/or pulse oximetry
- •presence of atrial fibrillation, atrial flutter, or normal sinus rhythm
排除标准
- •any subject deemed too unstable, at the clinician's discretion, to participate in the study
- •any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
- •any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
- •presence of peripheral vascular disease in arms
- •inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
- •if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
- •subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
结局指标
主要结局
Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards
时间窗: 1-4 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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