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

Recruiting

• Conditions: Cerebrospinal; Disorder

• Registration Number: NCT06350656
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-03-31
• Status Verified: 2024-04
• Primary Completion: 2024-04
• Study Completion: 2024-04
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Continuous intracranial pressure monitoring
• Sedated patient on mechanical ventilation

Exclusion Criteria

• Craniectomy
• Major hemodynamic failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intracranial pressure (mmHg)	Year : 1	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance	Year : 1	Compare the ICP (Intra Cranial Pressure) dose value with the compliance index during the period before or after the flattening

Trial Locations

Locations (7)

HOPITAL NORD La Tronche; 🇫🇷 La Tronche, France

Hopital Lariboisiere - Ahph; 🇫🇷 Paris, France

CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne; 🇫🇷 Saint-Étienne, France

CENTRE HOSPITALIER Charponnay; 🇫🇷 Chaponnay, France

CENTRE HOSPITALIER UNIVERSITAIRE Grenoble; 🇫🇷 Grenoble, France

CENTRE HOSPITALIER UNIVERSITAIRE Rennes; 🇫🇷 Rennes, France

APHP; 🇫🇷 Paris, France