A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- PPV
研究概览
简要总结
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available.
详细描述
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery and general anesthesia
- •age >/= 18 years
- •any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro surgery/cardio surgery (N=10)
- •cardio surgery (N=10)
- •Transcatheter Aortic Valve Implantation (N=20)
- •cystectomy (N=10)
- •neurosurgery with an expected postoperative ICU stay >/= 20 hours (N=10)
排除标准
- •pregnant or breastfeeding patients
- •emergency surgery
- •participation in a clinical interventional study
- •BMI >35 kg/m²
- •impossibility to place the ConCardiac interlayer
- •difference of blood pressure of right and left arm > 12 mmHg
- •pAVK Fontaine IV
- •arrythmia absoluta
- •vitium cordis >/=3
- •ejection fraction <35%
- •TAPSE </=16mm
- •need of IABP
结局指标
主要结局
PPV
时间窗: Duration of surgery and perioperative care (an average of 24 hours)
Percentual error of PPV \< 30% for ConCardiac between ConCardiac and PICCO
次要结局
- Duration of surgery(Duration of surgery (an average of 4 hours))
- Length of hospital stay(perioperative (an average of 10 days))
- Blood products and volume needed perioperative(perioperative (an average of 10 days))
- Duration of anesthesia(Duration of surgery (an average of 4 hours))
- Duration of mechanical ventilation(Duration of surgery (an average of 4 hours))
- Duration of renal replacement therapy(perioperative (an average of 10 days))
- intraoperative blood loss(Duration of surgery and perioperative care (an average of 24 hours))
- Vital signs of patients/blood pressure(perioperative (an average of 10 days))
- Vital signs of patients/heart frequency(perioperative (an average of 10 days))
- Vital signs of patients/stroke volume(perioperative (an average of 10 days))
- Vital signs of patients/central venous oxygen saturation(perioperative (an average of 10 days))
- Vital signs of patients/creatinine(perioperative (an average of 10 days))
- ICU scores (TISS)(perioperative (an average of 10 days))
- ICU scores (SOFA)(perioperative (an average of 10 days))
- Vital signs of patients/Cardiac index(perioperative (an average of 10 days))
- Vital signs of patients/intrathoracic blood volume index(perioperative (an average of 10 days))
- Vital signs of patients/central venous pressure(perioperative (an average of 10 days))
- ICU scores (SAPS)(perioperative (an average of 10 days))
- Vital signs of patients/systemic vascular resistance index(perioperative (an average of 10 days))
- Vital signs of patients/extra vascular lung water index(perioperative (an average of 10 days))
- Incidence of organ failure or complications(perioperative (an average of 10 days))
- Vital signs of patients/pulse pressure variation(perioperative (an average of 10 days))
- Vital signs of patients/global enddiastolic volume index(perioperative (an average of 10 days))
- Vital signs of patients/blood gases(perioperative (an average of 10 days))
- Vital signs of patients/Ventilator settings(perioperative (an average of 10 days))
- Vital signs of patients/diuresis(perioperative (an average of 10 days))
研究者
Sascha Treskatsch
Prof. Dr. med./ Deputy head of department
Charite University, Berlin, Germany