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.
Study Type
OBSERVATIONAL
Enrollment
30
The lower-body-low-pressure chamber administers a negative pressure to the lower part of the body (below the waist) to induce a central hypovolaemia by pooling of blood in the legs according to Tymko, M. FACETS, Bd. 1, Nr. 1, S. 225-244, März 2017 and Esch, B.T.A. et al. AJP Adv. Physiol. Educ., Bd. 31, Nr. 1, S. 76-81, März 2007.
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany
Berlin, Germany
Changes in the pulse-contour-analysis of the plethysmographic signal
The pulse-contour of the plethysmographic signal will be analyzed to detect morphological changes over time in relation to the initial baseline recording
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Changes the pulse-wave-transit-times of the plethysmographic signal
The pulse-wave-transit-times of the plethysmographic signal will be analyzed to detect changes over time in relation to the initial baseline recording
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Arterial blood pressure
Arterial blood pressure determined by non-invasive monitoring
Time frame: 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
Heart rate determined by non-invasive monitoring
Time frame: 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 ventricle
The performance of the left ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Time frame: 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
The performance of the left atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Time frame: 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
The performance of the right ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Time frame: 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
The performance of the right atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology
Time frame: 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
The analysis will be assessed by a subcostal approach by transthoracic echocardiography
Time frame: 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
Heart rate variability calculated from raw biosignals Bioelectrical signals by standardized analysis algorithms
Time frame: 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
The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical
Time frame: 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
The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Heart sounds
Heart sounds measured by vibration sensors
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Tonometric arterial blood pressure
Tonometric arterial blood pressure measured by applanation tonometer
Time frame: 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
The parameter will be determined by the non-invasive monitoring device Finapress
Time frame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Mean systemic filling pressure
The parameters describing the characteristics of the venous return determined by the stop-flow method
Time frame: 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)
Questionnaire regarding alimentation
The questionnaire directs to characterize the intake of fluid and solid alimentation prior to the study protocol
Time frame: Immediately prior to the start of the study protocol
Bio-impedance analysis of the body fluid
The bio-impedance analysis of the body fluid directs to determine the water content of the body
Time frame: Immediately prior to the start of the study protocol
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