- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06900101
Multimodal Monitoring Study in Neuro Critical Care (MultiCU)
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dr Baptiste Balança
- Phone Number: 04 72 35 75 76
- Email: baptiste.balanca@chu-lyon.fr
Study Locations
-
-
Bron
-
France, Bron, France, 69500
- Recruiting
- Hopital Pierre Wertheimer
-
Contact:
- Baptiste Balança
- Phone Number: 04 72 35 75 76
- Email: baptiste.balanca@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 713
Drug and device information, study documents
product manufactured in and exported from the U.S.
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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