Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement
研究概览
简要总结
Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med 2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz technique, a non-invasive measurement device is now available commercially. In this study, the reference technique based on arterial measurement and a respiratory variation monitor (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1: 307-10)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 80 years old
- •Written informed consent obtained
- •Patients scheduled for elective urological or abdominal surgery procedures in supine position
- •qualifying for arterial line
排除标准
- •pregnancy
- •cardiac insufficiency (NYHA 4, EF < 25 %)
- •coronary artery disease (CCS 4)
- •coagulopathy
- •symptoms of infection or sepsis
- •malignant hyperthermia
- •absence of sinus rhythm
- •BMI > 30
- •M. Raynaud
结局指标
主要结局
Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement
时间窗: intraoperatively
Systolic, diastolic, mean blood pressure and difference in pulse pressure are measured intraoperatively with a non-invasive device and the reference technique. The values are compared using Bland-Altmann Analysis.
次要结局
未报告次要终点
研究者
Verena Schnupp
M.D.
Johannes Gutenberg University Mainz