Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®)
研究概览
简要总结
Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - APACHE II score).
详细描述
The measurements have to estimate the agreement of esCCO™ and PiCCO® related to the cardiac output (cardiac index). It should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (esCCO™) and the transcardiopulmonal thermodilution technique (PiCCO®). The accuracy shall carve out as well as the power of agreement of both measurement methods.
It takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. Furthermore the force of the major variables (1. requirement of norepinephrine and 2. APACHE II-score) to the estimators shall be realized.
esCCO™ vs. (PiCCO®)
This research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions.
During a daily screening within the interdisciplinary surgical intensive care units of the Universitätsklinikum Schleswig-Holstein, Campus Kiel it will be opted for the inclusion of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team
排除标准
- •atrial fibrillation
- •cardiac arrhythmias
- •cardiac pacemaker
- •intraaortic counterpulsation
- •pericardial tamponade
- •age < 18 years
- •missing or incorrect patient consent form
结局指标
主要结局
Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®)
时间窗: through study completion, an average of 1 year
Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)
次要结局
- Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease)(through study completion, an average of 1 year)
研究者
Dr. Jochen Renner
PD Dr.
University Hospital Schleswig-Holstein