Clinical trial NCT03481855: Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation
Official title: Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health, Subjective
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Technische Universität Berlin
First posted: 2018-03-29
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the pulse-contour-analysis of the plethysmographic signal
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Changes the pulse-wave-transit-times of the plethysmographic signal
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
Secondary outcomes:
measure: Arterial blood pressure
timeFrame: 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)
measure: Heart rate
timeFrame: 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)
measure: Echocardiographic parameter to determine the cardiac performance of the left ventricle
timeFrame: 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)
measure: Echocardiographic parameter to determine the cardiac performance of the left atrium
timeFrame: 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)
measure: Echocardiographic parameter to determine the cardiac performance of the right ventricle
timeFrame: 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)
measure: Echocardiographic parameter to determine the cardiac performance of the right atrium
timeFrame: 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)
measure: Echocardiographic parameter to analyze the vena cava inferior
timeFrame: 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)
measure: Heart rate variability
timeFrame: 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)
measure: Haemodynamic parameter of the bio-impedance monitoring
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Shock indices of the bio-impedance monitoring
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Heart sounds
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Tonometric arterial blood pressure
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Haemodynamic parameter of the tonometric pulse-contour method
timeFrame: Time course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)
measure: Mean systemic filling pressure
timeFrame: 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)
measure: Questionnaire regarding alimentation
timeFrame: Immediately prior to the start of the study protocol
measure: Bio-impedance analysis of the body fluid
timeFrame: Immediately prior to the start of the study protocol
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany, 13353 Berlin
name: Aarne Feldheiser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: