Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)

Cerebrospinal; Disorder Clinical Trial

— EC2  

Official title:

Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350656
• Other study ID #: IRBN282022/CHUSTE
• Status: Recruiting
• Start date: March 31, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: LAURENT GERGELE, MD
• Phone: (0)477828593
• Email: laurent.gergele[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study aims to analyse the shape of the different components of the intracranial pressure waves (P1, P2, and P3) when the patient is flattened to determine an index to define the level of cerebral compliance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Continuous intracranial pressure monitoring

• Sedated patient on mechanical ventilation

Exclusion Criteria:

• Craniectomy

• Major hemodynamic failure

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cerebrospinal; Disorder

Intervention

Other:
• Clinical data collection
Post-retrieval from the medical record
• Therapeutic data collection
Post-retrieval from the medical record
• IntraCranial Pression (ICP) values collection
Post-retrieval of ICP values from the monitor

Locations

Country	Name	City	State
France	CENTRE HOSPITALIER Charponnay	Chaponnay
France	CENTRE HOSPITALIER UNIVERSITAIRE Grenoble	Grenoble
France	HOPITAL NORD La Tronche	La Tronche
France	APHP	Paris
France	Hopital Lariboisiere - Ahph	Paris
France	CENTRE HOSPITALIER UNIVERSITAIRE Rennes	Rennes
France	CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance	Compare the ICP (Intra Cranial Pressure) dose value with the compliance index during the period before or after the flattening	Year : 1