Research of Optimal Cerebral Perfusion Pressure Diagnosis

NCT06028906 | Unknown

• 2 other identifiers: OptCPP, ver BMIP-20-216
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Trauma, Brain; Hemorrhage Cerebral

Keywords

optimal cerebral perfusion pressure; optimal arterial pressure; cerebral autoregulation

Outcome Measures

Primary Outcomes (3)

• Cerebral autoregulation index (pressure reactivity index PRx)

  Negative values of cerebral autoregulation index (PRx\<0) represent intact cerebral autoregulation, positive values (PRx\>0) show impaired cerebral autoregulation.

  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).

• Cerebral autoregulation index (mean flow index Mx)

  Negative values of cerebral autoregulation index (Mx\<0) represent intact cerebral autoregulation, positive values (Mx\>0) show impaired cerebral autoregulation.

  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).

• Optimal arterial blood pressure value

  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.

  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).

Secondary Outcomes (2)

• Patients' outcome

  GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission.

• Occurrence of cerebral ischemia and cerebral vasospasms

  CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary.

Interventions

Multimodal physiological monitoring and cerebral autoregulation monitoring DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Traumatic brain injury patients
• Subarachnoid hemorrhage patients

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vilnius University: lead
• Kaunas University of Technology: collaborator

Study Sites (1)

Vilnius University Hospital Santaros klinikos

Vilnius, 08661, Lithuania

RECRUITING

Related Publications (1)

• Chaleckas E, Putnynaite V, Lapinskiene I, Preiksaitis A, Serpytis M, Rocka S, Bartusis L, Petkus V, Ragauskas A. Impaired cerebral autoregulation detected in early prevasospasm period is associated with unfavorable outcome after spontaneous subarachnoid hemorrhage: an observational prospective pilot study. Ultrasound J. 2024 Apr 15;16(1):24. doi: 10.1186/s13089-024-00371-8.

  PMID: 38619783 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saulius Rocka

  Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saulius Rocka, Prof. Dr.

CONTACT

+37068743480; saulius.rocka@santa.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 8, 2023
• Study Start: June 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)