Research of Optimal Cerebral Perfusion Pressure Diagnosis

Trauma, Brain Clinical Trial

— optCPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028906
• Other study ID #: OptCPP, ver B
• Secondary ID: MIP-20-216
• Status: Recruiting
• Start date: June 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Vilnius University
• Contact: Saulius Rocka, Prof. Dr.
• Phone: +37068743480
• Email: saulius.rocka[@]santa.lt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Cerebral Hemorrhage
• Hemorrhage
• Trauma, Brain

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Kaunas University of Technology

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	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.
Secondary	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.