Evaluation of a Non-invasive Cardiac Output Monitoring System in Comparison to the Semi-invasive Monitoring System FloTrac VigileoTechnology in Elderly Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cardiac output
研究概览
简要总结
There are different methods for measuring cardiac output (CO) completely non-invasive, which are used today. Two of these should be used in the study to examine the CO in an older group of patients (> 65 years) undergoing major trauma surgery. The first method is the esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully non-invasive.
The measured data will be compared to established standard procedures like semi-invasive pulse contour analysis using the Flotrac-Vigileo system. The study should answer the following questions:
How accurate and precise are the non-invasive methods? How large is the percentage deviation in comparison to the established standard? Are there any limitations of measuring accuracy regarding the age of the patient? The continuous hemodynamic monitoring of patients during surgery has recently changed from invasive and semi-invasive methods to completely non-invasive technologies. The accuracy and precision of this way of measuring cardiovascular parameters in comparison to the invasive standard is still controversial. Especially for older patient with atherosclerotic alteration of the blood vessels the utility of non-invasive monitoring systems is not shown yet. But principally this group with a high level of comorbidity might profit notably from less invasive procedures. This is the reason for the planed research.
详细描述
The Nexfin® monitoring system by Edwards life sciences could measure continuous non-invasive blood pressure through a finger-cuff for every single heart beat; moreover it calculates a CO and stroke-volume parameter utilizing a so-called pulse contour analysis provided by the non-invasive blood pressure measurement. This technology is based on an inflatable doublefinger-cuff wristband, which is attached to the patients hand and connected to a monitor. Using this wristband the arterial pressure within the patient's digital arteries will be continuously registered. Using a heart-frequency adapted algorithm - based on an alignment chart including healthy patients, patients with arterial hypertonia and micro/macro angiopathia - the software is also able to measure the brachial artery blood pressure.
First evaluations regarding non-invasive blood pressure measurement were very promising. However, data especially in elderly patients and patients with vascular disease are still not available.
The esCCO monitor (estimated Continuous Cardiac Output) by Nihon Kohden (Nihon Kohden Europe GmbH, 61191 Rosbach, Deutschland) is another completely non-invasive measurement device, which is based on the pulse wave transit time (PWTT) as well as non-invasive blood pressure measurement, ECG and pulse oximetry. PWTT provides time adapted information, e.g. intravascular pressure transmission or information on changes in the arterial blood volume.
Besides common vital signs such as SpO2, RR and ECG, esCCO™ also offers a realtime non-invasive CO-measurement. Mainly, the esCCO™ principle is based on the possibility to obtain CO-values using pulse pressure analysis: CO = SV × HR = (C × PP) × HR [SV: stroke volume; C: constant value; PP: Pulse Pressure; HR: Heart Rate]. Since studies have shown that there is a greater correlation between SV and PWTT than between SV and PP, the CO calculation was stated as followed as a result of the PWTT information: CO = SV × HR= C × (α × PWTT ＋ β) × HR = esCCO [α, β: experimental constants].
Demographic changes but also clinical everyday life indicates a strong increase in older patients undergoing surgery. The percentages of risk or high-risk patients with relevant comorbidities will therefore tremendously increase as well. If it is possible to adequately monitor this particular collective continuously with even less invasive technologies is to be answered by this clinical trial.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major surgery (elective or urgent) in vascular surgery and trauma surgery
- •Patient´s rating according to ASA physical status classification system with 2-4
- •Written consent by patient
- •Age > 65
排除标准
- •Patient requiring high doses of catecholamine already before surgery
- •Cognitive or language barriers restricting informant consent of patient
- •Denial of participation by the patient
- •emergency surgery
结局指标
主要结局
cardiac output
时间窗: through study completion, an average of 1,5 years
Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™ Nihon Khoden) and the Flotrac-Vigileo (Edward Lifesciences) monitoring system.
次要结局
- pulse wave transit time (PWTT)(through study completion, an average of 1,5 years)
研究者
Dr. Jochen Renner
PD Dr. Jochen Renner
University Hospital Schleswig-Holstein