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

April 3, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Chaponnay, France, 69970
        • Recruiting
        • CENTRE HOSPITALIER Charponnay
        • Principal Investigator:
          • PIERRE-HENRI MURGAT, MD
      • Grenoble, France, 38000
        • Recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE Grenoble
        • Principal Investigator:
          • JEAN FRANCOIS PAYEN, MD
      • La Tronche, France, 38170
        • Recruiting
        • HOPITAL NORD La Tronche
        • Principal Investigator:
          • KEVIN LAGARDE, MD
      • Paris, France, 75010
        • Recruiting
        • APHP
        • Principal Investigator:
          • SAMUEL GAUGUIN, MD
      • Paris, France, 75010
        • Recruiting
        • Hopital Lariboisiere - Ahph
        • Principal Investigator:
          • JEROME CARTAILLIER, MD
      • Rennes, France, 35000
        • Recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE Rennes
        • Principal Investigator:
          • YOANN LAUNEY, MD PHD
      • Saint-Étienne, France, 42055
        • Recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne
        • Principal Investigator:
          • CLEMENT MAGAND, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring

Description

Inclusion Criteria:

  • Continuous intracranial pressure monitoring
  • Sedated patient on mechanical ventilation

Exclusion Criteria:

  • Craniectomy
  • Major hemodynamic failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial pressure (mmHg)
Time Frame: 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.
Year : 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: LAURENT GERGELE, MD, CHU DE SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Estimated)

April 5, 2024

Study Record Updates

Last Update Posted (Estimated)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN282022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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