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Research of Optimal Cerebral Perfusion Pressure Diagnosis (optCPP)

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ClinicalTrials.gov Identifier: NCT06028906
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : September 8, 2023
Sponsor:
Collaborator:
Kaunas University of Technology
Information provided by (Responsible Party):
Vilnius University

Study Description
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Brief Summary:

The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow,

This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes).

The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery.

The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits.

Objectives of the study

  1. To perform a prospective observational study by collecting multimodal physiological brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP), End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.
  2. To perform a retrospective analysis of the accumulated clinical monitoring data, in order to create an algorithm for the identification of informative monitoring data fragments, according to which it would be possible to identify the optimal cerebral perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen minutes).
  3. To perform a retrospective analysis of accumulated clinical monitoring data, determining correlations of cerebral blood flow autoregulation and optCPP-related parameters with the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral ischemia.

Condition or disease Intervention/treatment
Trauma, Brain Hemorrhage Cerebral Diagnostic Test: Multimodal physiological monitoring and cerebral autoregulation monitoring

Detailed Description:

Optimal cerebral perfusion pressure (optCPP) management requires at least 4 hours of patients' physiological data monitoring. Critical pathophysiological events in the injured brain happen in minutes, not in hours.

The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow,

This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes).

The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery.

The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits.

Objectives of the study

  1. To perform a prospective observational study by collecting multimodal physiological brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP), End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG.
  2. To perform a retrospective analysis of the accumulated clinical monitoring data, in order to create an algorithm for the identification of informative monitoring data fragments, according to which it would be possible to identify the optimal cerebral perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen minutes).
  3. To perform a retrospective analysis of accumulated clinical monitoring data, determining correlations of cerebral blood flow autoregulation and optCPP-related parameters with the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral ischemia.

Timely identification of optCPP value and diagnosis of cerebrovascular autoregulation (CA) will be performed according to the measured reaction of cerebral hemodynamics during the detected ABP(t) changes.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research and Development of Innovative Method and Technology for Cerebral Perfusion Pressure Diagnosis
Actual Study Start Date : June 21, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Multimodal physiological monitoring and cerebral autoregulation monitoring

    Patients are monitored routinely during their treatment in ICU. Multimodal physiological monitoring include continuous monitoring of arterial blood pressure (ABP), intracranial pressure (ICP) (if available), ETCO2 (if available), cerebral perfusion pressure (if available), cerebral blood flow velocity (CBFV) and ECG.

    Non-invasive cerebral autoregulation index Mx will by calculated as a Pearson correlation coefficient between slow ABP and slow CBFV waves.

    Invasive cerebral autoregulation index (Pressure reactivity index PRx) will by calculated as a Pearson correlation coefficient between slow ABP and slow ICP waves.

    Non invasive CBFV will be measured by using TCD device DWL Multi Dop-T. Invasive ICP will be measured by using Codman ICP Express or Raumedic ICP monitor.


Outcome Measures
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Primary Outcome Measures :
  1. Cerebral autoregulation index (pressure reactivity index PRx) [ Time Frame: PRx is measured when invasive intracranial pressure slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days). ]
    Negative values of cerebral autoregulation index (PRx<0) represent intact cerebral autoregulation, positive values (PRx>0) show impaired cerebral autoregulation.

  2. Cerebral autoregulation index (mean flow index Mx) [ Time Frame: Mx is measured when non-invasive cerebral blood flow slow waves and arterial pressure slow waves are available during multimodal clinical data collection in ICU (up to 7 days). ]
    Negative values of cerebral autoregulation index (Mx<0) represent intact cerebral autoregulation, positive values (Mx>0) show impaired cerebral autoregulation.

  3. Optimal arterial blood pressure value [ Time Frame: Optimal arterial blood pressure value is identified when PRx or Mx data are available during multimodal clinical data collection in ICU (up to 7 days). ]

    Optimal arterial blood pressure value is identified at the conditions of lowest values of cerebral autoregulation indexes by applying "U-shape" approximation on ABP and PRx (or Mx) data.

    Identified optimal arterial blood pressure value is assumed as a targeted arterial blood pressure value for personalized cerebral perfusion management in the cases when U-shape approximation is determined.



Secondary Outcome Measures :
  1. Patients' outcome [ Time Frame: GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission. ]
    Patients' outcome is evaluated according to Glasgow Outcome Score (GOS). GOS scores are: 1 - death, 2 - persistent vegetative state, 3 - severe disability, 4 - moderate disability, 5 - low disability.

  2. Occurrence of cerebral ischemia and cerebral vasospasms [ Time Frame: CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary. ]
    Occurrence of cerebral ischemia and cerebral vasospasms evaluated from Computed Tomography (CT) and Computed Tomography Angiography (CTA) scans


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include patients treated at Vilnius University Hospital Santaros Klinikos that undergo brain surgery after traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).
Criteria

Inclusion Criteria:

  • Traumatic brain injury patients
  • Subarachnoid hemorrhage patients

Exclusion Criteria:

  • persons with mental disorders, but who can give consent to participate in biomedical research;
  • minors;
  • students, if their participation in biomedical research is related to studies;
  • persons living in care institutions;
  • soldiers during their actual military service;
  • employees of health care institutions where biomedical research is conducted, subordinate to the researcher;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028906


Contacts
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Contact: Saulius Rocka, Prof. Dr. +37068743480 saulius.rocka@santa.lt

Locations
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Lithuania
Vilnius University Hospital Santaros klinikos Recruiting
Vilnius, Lithuania, 08661
Contact: Saulius Rocka, Prof. Dr.    +37068743480    saulius.rocka@santa.lt   
Contact: Aidanas Preiksaitis, Dr    +37065915104    danas911@gmail.com   
Sponsors and Collaborators
Vilnius University
Kaunas University of Technology
Investigators
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Principal Investigator: Saulius Rocka Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos
More Information
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Responsible Party: Vilnius University
ClinicalTrials.gov Identifier: NCT06028906    
Other Study ID Numbers: OptCPP, ver B
MIP-20-216 ( Other Grant/Funding Number: Research Council of Lithuania )
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vilnius University:
optimal cerebral perfusion pressure
optimal arterial pressure
cerebral autoregulation
Additional relevant MeSH terms:
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Brain Injuries, Traumatic
Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases