Multimodal Monitoring Study in Neuro Critical Care (MultiCU)

March 21, 2025 updated by: Hospices Civils de Lyon

During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders.

Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS).

Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.

Study Overview

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Bron
      • France, Bron, France, 69500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients hospitalized in neuro critical care, in Pierre Wertheimer hospital, for acute brain injury and monitored by MOBERG® system.

Description

Inclusion Criteria:

  • - Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
  • Monitored with the CNS MOBERG® monitoring system

Exclusion Criteria:

  • - Refusal to participate
  • Patients under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury,

Objective n°1: Study the correlation between autoregulation index:

The investigators will look for a correlation between several auroregulation index such as the PRx, ORx and Cox.

Objective n°2: Evaluation and detection of EEG prognostic patterns: The investigators will look for quantitaive EEG changes during the early phase of acute brain injuries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between ORx and PRx
Time Frame: Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.
Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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