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NCT Number: NCT03481855

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

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.

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Key information

Conditions

Health, Subjective

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

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

Berlin, 13353, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower-body-low-pressure chamber

Device

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.

Primary outcomes

  1. Changes in the pulse-contour-analysis of the plethysmographic signal

    Time frame: 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

  2. Changes the pulse-wave-transit-times of the plethysmographic signal

    Time frame: 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 outcomes

  1. Arterial blood pressure

    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)

    Arterial blood pressure determined by non-invasive monitoring

  2. Heart rate

    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 determined by non-invasive monitoring

  3. Echocardiographic parameter to determine the cardiac performance of the left ventricle

    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)

    The performance of the left ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology

  4. Echocardiographic parameter to determine the cardiac performance of the left atrium

    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)

    The performance of the left atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology

  5. Echocardiographic parameter to determine the cardiac performance of the right ventricle

    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)

    The performance of the right ventricle will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology

  6. Echocardiographic parameter to determine the cardiac performance of the right atrium

    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)

    The performance of the right atrium will be analyzed by a transthoracic echocardiography by a physician certified by the European Society of Cardiology

  7. Echocardiographic parameter to analyze the vena cava inferior

    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)

    The analysis will be assessed by a subcostal approach by transthoracic echocardiography

  8. Heart rate variability

    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 calculated from raw biosignals Bioelectrical signals by standardized analysis algorithms

  9. Haemodynamic parameter of the bio-impedance monitoring

    Time frame: 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

  10. Shock indices of the bio-impedance monitoring

    Time frame: 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

  11. Heart sounds

    Time frame: 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

  12. Tonometric arterial blood pressure

    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 measured by applanation tonometer

  13. Haemodynamic parameter of the tonometric pulse-contour method

    Time frame: 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

  14. Mean systemic filling pressure

    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)

    The parameters describing the characteristics of the venous return determined by the stop-flow method

  15. Questionnaire regarding alimentation

    Time frame: 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

  16. Bio-impedance analysis of the body fluid

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Technische Universität Berlin

Registry information

Acronym: Plethysmo

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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