Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in the pulse-contour-analysis of the plethysmographic signal
研究概览
简要总结
The evaluation of haemodynamic changes is still challenging in clinically relevant situations (e.g. in bleeding, septic and postoperative patients) with the conventional monitoring routinely used including heart rate and mean arterial pressure. If the arterial pressure drops and the heart increases, the haemodynamic state is already decompensated and a therapy is at risk being indicated too late.
Prior to decompensation - still in the state of compensated shock - it would be desirable to detect the shock already. The compensated shock is characterized by an occult drop of cardiac output and a hypoperfusion of vital organs like e.g. the splanchnic region. Due to these pathophysiological characteristics, a therapy would be indicated already in this stadium of shock progression.
The available monitoring tools to detect compensated shock are on the one hand side invasive (intravascular catheter), cost-intensive (cost of the catheter systems), or need extensive training (echocardiography). Consequently, the implementation of advanced haemodynamic monitoring is still low despite the high clinical relevance for the patients.
It is the goal of this project to evaluate in healthy volunteers the routinely implemented technology of photo-plethysmography in its ability to detect haemodynamic changes by extended signal analysis of the pulse-contour and the pulse-wave-transit-times in relation to the gold-standard echocardiography.
Secondary goal of this study is to analyse the physiological and haemodynamic changes during progressive central hypovolaemia displayed by non-invasive or minimal-invasive monitoring devices and associate the changes to each other.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Offered patient information and written informed consent
- •Existence of valid health insurance
- •Male gender
排除标准
- •Patients aged less than 18 years or more than 40 years
- •Inability of German language use
- •Lacking willingness to save and hand out data within the study
- •Evidence of a chronic disease (cardio-vascular, renal, pulmonary, neurological, metabolic, gastro-intestinal)
- •Chronic medication
- •Signs of a reduced cardiorespiratory capacity
- •Signs of an acute illness
- •Participation in a prospective intervention trial during the study period
- •Anamnestic hints for syncope or disposition to hypotension
- •Signs of arterial hypertension
- •Signs of inguinal hernia
- •Relevant pathologies in the baseline examination of the transthoracic echocardiography
- •For the bio-impedance measurements: heart defibrillator
结局指标
主要结局
Changes in the pulse-contour-analysis of the plethysmographic signal
时间窗: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
The pulse-contour of the plethysmographic signal will be analyzed to detect morphological changes over time in relation to the initial baseline recording
Changes the pulse-wave-transit-times of the plethysmographic signal
时间窗: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
The pulse-wave-transit-times of the plethysmographic signal will be analyzed to detect changes over time in relation to the initial baseline recording
次要结局
- Questionnaire regarding alimentation(Immediately prior to the start of the study protocol)
- Echocardiographic parameter to determine the cardiac performance of the left ventricle(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Echocardiographic parameter to determine the cardiac performance of the left atrium(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Echocardiographic parameter to determine the cardiac performance of the right atrium(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Arterial blood pressure(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Heart rate(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Echocardiographic parameter to determine the cardiac performance of the right ventricle(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Echocardiographic parameter to analyze the vena cava inferior(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Heart rate variability(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Haemodynamic parameter of the bio-impedance monitoring(Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time))
- Haemodynamic parameter of the tonometric pulse-contour method(Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time))
- Shock indices of the bio-impedance monitoring(Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time))
- Mean systemic filling pressure(At baseline (up to minute 7 after starting the study protocol), during the study intervention level 1, 2 and 3 (between minute 8 up to minute 28 after starting study protocol) and recovery after finishing the study intervention (between minute 30 and 40))
- Heart sounds(Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time))
- Tonometric arterial blood pressure(Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time))
- Bio-impedance analysis of the body fluid(Immediately prior to the start of the study protocol)
研究者
Aarne Feldheiser
Priv.-Doz. Dr. med. Aarne Feldheiser
Charite University, Berlin, Germany