Plethysmographic Pulse-contour and Pulse-wave-transit-times for Haemodynamic Evaluation in Bleeding Simulation (Plethysmo)

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 Overview

• Status: Completed
• Conditions: Health, Subjective
• Intervention / Treatment: Device: Lower-body-low-pressure chamber

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Progressive bleeding simulation; The study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with progressive increase of negative pressure by a step-wise approach (-15mmHg, -30mmHg, -45mmHg).	Device: Lower-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.
Prolonged bleeding simulation; The study intervention by a lower-body-low-pressure chamber is performed in this group of healthy volunteers with prolonged exposure to a negative pressure of -15mmHg.	Device: Lower-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 course of 40 minutes (at study baseline, at study intervention level 1, 2 and 3 and recovery time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood pressure	Arterial blood pressure determined by non-invasive monitoring	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	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	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	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	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	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	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	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 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 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 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 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 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	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	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	Immediately prior to the start of the study protocol

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Technische Universität Berlin
• Investigators: Principal Investigator: Aarne Feldheiser, MD, PhD, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow Klinikum, Charité - University Medicine Berlin Berlin, Germany, 13353 Berlin

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: EA1/249/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No