Research of Optimal Cerebral Perfusion Pressure Diagnosis

NCT ID: NCT06028906

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma, Brain Hemorrhage Cerebral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaunas University of Technology

OTHER

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saulius Rocka

Role: PRINCIPAL_INVESTIGATOR

Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos

Locations

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Vilnius University Hospital Santaros klinikos

Vilnius, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Saulius Rocka, Prof. Dr.

Role: CONTACT

+37068743480

Facility Contacts

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Saulius Rocka, Prof. Dr.

Role: primary

+37068743480

Aidanas Preiksaitis, Dr

Role: backup

+37065915104

References

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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.

Reference Type DERIVED
PMID: 38619783 (View on PubMed)

Other Identifiers

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MIP-20-216

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OptCPP, ver B

Identifier Type: -

Identifier Source: org_study_id

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