Health, Subjective
Conditions
Brief summary
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.
Interventions
DEVICELower-body-low-pressure chamber
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.
Sponsors
Technische Universität Berlin
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Inclusion criteria
* Offered patient information and written informed consent * Existence of valid health insurance * Male gender
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the pulse-contour-analysis of the plethysmographic signal | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | The performance of the left ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology |
| 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) | The performance of the left atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology |
| 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) | The performance of the right ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology |
| 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) | The performance of the right atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology |
| 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) | The analysis will be assessed by a subcostal approach by transthoracic echocardiography |
| 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) | Heart rate variability calculated from raw biosignals Bioelectrical signals by standardized analysis algorithms |
| 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) | The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical |
| 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) | Arterial blood pressure determined by non-invasive monitoring |
| Heart sounds | Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time) | Heart sounds measured by vibration sensors |
| Tonometric arterial blood pressure | Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time) | Tonometric arterial blood pressure measured by applanation tonometer |
| 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) | The parameter will be determined by the non-invasive monitoring device Finapress |
| 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) | The parameters describing the characteristics of the venous return determined by the stop-flow method |
| Questionnaire regarding alimentation | Immediately prior to the start of the study protocol | The questionnaire directs to characterize the intake of fluid and solid alimentation prior to the study protocol |
| Bio-impedance analysis of the body fluid | Immediately prior to the start of the study protocol | The bio-impedance analysis of the body fluid directs to determine the water content of the body |
| 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) | The parameter will be determined by the electrical cardiometry/bio-impedance monitoring device of Osypka Medical |
| 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) | Heart rate determined by non-invasive monitoring |
Countries
Germany
Outcome results
None listed