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

NCT ID: NCT06350656

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebrospinal; Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Clinical data collection

Post-retrieval from the medical record

Intervention Type OTHER

Therapeutic data collection

Post-retrieval from the medical record

Intervention Type OTHER

IntraCranial Pression (ICP) values collection

Post-retrieval of ICP values from the monitor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Continuous intracranial pressure monitoring
* Sedated patient on mechanical ventilation

Exclusion Criteria

* Craniectomy
* Major hemodynamic failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LAURENT GERGELE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU DE SAINT-ETIENNE

Locations

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CENTRE HOSPITALIER Charponnay

Chaponnay, , France

Site Status RECRUITING

CENTRE HOSPITALIER UNIVERSITAIRE Grenoble

Grenoble, , France

Site Status RECRUITING

HOPITAL NORD La Tronche

La Tronche, , France

Site Status RECRUITING

APHP

Paris, , France

Site Status RECRUITING

Hopital Lariboisiere - Ahph

Paris, , France

Site Status RECRUITING

CENTRE HOSPITALIER UNIVERSITAIRE Rennes

Rennes, , France

Site Status RECRUITING

CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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LAURENT GERGELE, MD

Role: CONTACT

(0)477828593 ext. +33

Other Identifiers

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IRBN282022/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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