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| ID | Type | Description | Link |
|---|---|---|---|
| MIP-20-216 | Other Grant/Funding Number | Research Council of Lithuania |
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| Name | Class |
|---|---|
| Kaunas University of Technology | OTHER |
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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
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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' outcome | 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. | GOS is evaluated at discharge from hospital and after 30 days of patient's hospital admission. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saulius Rocka, Prof. Dr. | Contact | +37068743480 | saulius.rocka@santa.lt |
| Name | Affiliation | Role |
|---|---|---|
| Saulius Rocka | Head of the Neurosurgery Center at Vilnius University Hospital Santaros klinikos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University Hospital Santaros klinikos | Recruiting | Vilnius | 08661 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38619783 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Occurrence of cerebral ischemia and cerebral vasospasms |
Occurrence of cerebral ischemia and cerebral vasospasms evaluated from Computed Tomography (CT) and Computed Tomography Angiography (CTA) scans |
| CT and CTA scans is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |