Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
EC2
1 other identifier
observational
30
1 country
7
Brief Summary
Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy. In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedStudy Start
First participant enrolled
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedApril 5, 2024
April 1, 2024
1 year
March 31, 2023
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracranial pressure (mmHg)
Intracranial pressure is measured before (Raising the head by 30°) and during the flattening (Raising the head by 0°). Theses measures are done twice a day. The mean of theses values is calculated.
Year : 1
Secondary Outcomes (1)
Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance
Year : 1
Interventions
Post-retrieval from the medical record
Post-retrieval from the medical record
Post-retrieval of ICP values from the monitor
Eligibility Criteria
Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring
You may qualify if:
- Continuous intracranial pressure monitoring
- Sedated patient on mechanical ventilation
You may not qualify if:
- Craniectomy
- Major hemodynamic failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CENTRE HOSPITALIER Charponnay
Chaponnay, 69970, France
CENTRE HOSPITALIER UNIVERSITAIRE Grenoble
Grenoble, 38000, France
HOPITAL NORD La Tronche
La Tronche, 38170, France
APHP
Paris, 75010, France
Hopital Lariboisiere - Ahph
Paris, 75010, France
CENTRE HOSPITALIER UNIVERSITAIRE Rennes
Rennes, 35000, France
CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LAURENT GERGELE, MD
CHU DE SAINT-ETIENNE
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 5, 2024
Study Start
March 31, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
April 5, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share