Functional hemodynamic monitoring using Continuous Non invasive Arterial Pressure (CNAP) and Capstesia software
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cardiac Output measured by CNAP/ Capstesia combination
研究概览
简要总结
This is a single blind, prospective, observational, single arm, single centric, cohort study comparing the conventional cardiac output monitor Vigileo TM and IAP (Invasive arterial pressure) combination with the new smartphone based application Capstesia TM and CNAP (Continuous non invasive arterial pressure) combination in 50 consecutive adult patients undergoing major surgery requiring cardiac output monitoring. The primary outcome measure will be cardiac output measured by Capstesia TM at time points 5, 10 , 15, 20, 25, 30, 35, 40 , 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision. The secondary outcome measure would be the Pulse pressure variation (PPV) measured by Capstesia TM at time points 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status II and III 2) Adult patients (
- •75 yrs) of age 3) Either sex 4) Patients with a clinical need for invasive arterial pressure (IAP) monitoring 5) Expected duration of anesthesia > 120 min 6) Body mass index (BMI) between 18.
- •30.0 kg/m2 7) Weight between 45.
排除标准
- •Patients with advanced dysfunction of peripheral perfusion (e.g. arterial peripheral artery occlusive disease, Raynaud’s syndrome), arteriovenous shunts for hemodialysis 2) Any history of vascular surgery of the upper extremities 3) History of cardiac arrhythmia 4) Refusal to provide informed consent.
结局指标
主要结局
Cardiac Output measured by CNAP/ Capstesia combination
时间窗: 5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins
次要结局
- Pulse Pressure Variation (PPV) measured by Capstesia(5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins)