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

NCT ID: NCT03481855

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2018-04-11

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Lower-body-low-pressure chamber

Intervention Type: 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.

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.

Lower-body-low-pressure chamber

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Berlin

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Aarne Feldheiser

Priv.-Doz. Dr. med. Aarne Feldheiser

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aarne Feldheiser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37265333 (View on PubMed)

Other Identifiers

EA1/249/17

Identifier Type: -

Identifier Source: org_study_id