NCT06028906

Research of Optimal Cerebral Perfusion Pressure Diagnosis

Research and Development of Innovative Method and Technology for Cerebral Perfusion Pressure Diagnosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma, Brain
• Hemorrhage Cerebral

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-21
• Primary completion: 2023-12-31
• Completion: 2024-12-01
• First posted: 2023-09-08
• Last updated: 2023-09-08

Locations

1 site across 1 country: Lithuania