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

NCT03481855 | Completed

• 1 other identifier: EA1/249/17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

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

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

Interventions

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.

Progressive bleeding simulation; Prolonged bleeding simulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• Offered patient information and written informed consent
• Existence of valid health insurance
• Male gender

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Technische Universität Berlin: collaborator

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (1)

• Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.

  PMID: 37265333 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med. Aarne Feldheiser

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: March 6, 2018
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

DE (1)