Clinical trial NCT06028906: Research of Optimal Cerebral Perfusion Pressure Diagnosis
Official title: Research and Development of Innovative Method and Technology for Cerebral Perfusion Pressure Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma, Brain
Hemorrhage Cerebral
Keywords: optimal cerebral perfusion pressure
optimal arterial pressure
cerebral autoregulation
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Kaunas University of Technology
First posted: 2023-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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;

Primary outcomes:
measure: Cerebral autoregulation index (pressure reactivity index PRx)
timeFrame: 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).
measure: Cerebral autoregulation index (mean flow index Mx)
timeFrame: 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).
measure: Optimal arterial blood pressure value
timeFrame: 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:
measure: Patients' outcome
timeFrame: GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission.
measure: Occurrence of cerebral ischemia and cerebral vasospasms
timeFrame: CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary.
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos
Study officials:
affiliation: Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos
name: Saulius Rocka
role: PRINCIPAL_INVESTIGATOR
References: