Cerebrospinal; DisorderEC2NCT06350656
Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
An observational study of Cerebrospinal; Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrospinal; Disorder
- What is being tested?
- Clinical data collection, Therapeutic data collection and IntraCranial Pression (ICP) values collection
- How many people
- 30 participants
- Where
- 7 sitesFrance
- Study dates
- 31 Mar 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring
Who may be able to join
- Continuous intracranial pressure monitoring
- Sedated patient on mechanical ventilation
Who cannot join
- Craniectomy
- Major hemodynamic failure
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CENTRE HOSPITALIER Charponnay
Chaponnay, 69970
PIERRE-HENRI MURGAT, MD
- Recruiting
CENTRE HOSPITALIER UNIVERSITAIRE Grenoble
Grenoble, 38000
JEAN FRANCOIS PAYEN, MD
- Recruiting
HOPITAL NORD La Tronche
La Tronche, 38170
KEVIN LAGARDE, MD
- Recruiting
APHP
Paris, 75010
SAMUEL GAUGUIN, MD
- Recruiting
Hopital Lariboisiere - Ahph
Paris, 75010
JEROME CARTAILLIER, MD
- Recruiting
CENTRE HOSPITALIER UNIVERSITAIRE Rennes
Rennes, 35000
YOANN LAUNEY, MD PHD
- Recruiting
CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne
Saint-Etienne, 42055
CLEMENT MAGAND, MD
About this study
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.
Read the 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.
- Conditions
- Cerebrospinal; Disorder
- Being tested
- Clinical data collection, Therapeutic data collection, IntraCranial Pression (ICP) values collection
- Keywords
- Cerebrospinal compliance, Intracranial pressure., Head injury, Pulse waveform
- Medical subject headings
- Central Nervous System Diseases, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical data collectionOther
Post-retrieval from the medical record
Therapeutic data collectionOther
Post-retrieval from the medical record
IntraCranial Pression (ICP) values collectionOther
Post-retrieval of ICP values from the monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year : 1
Secondary outcomes (1)
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
Measured: Year : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start31 Mar 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal; DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT GERGELE, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350656
- Sponsor's protocol ID
- IRBN282022/CHUSTE
- Acronym
- EC2
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
- ClinicalTrials.gov ID
- NCT06350656
- Acronym / sponsor ID
- EC2 / IRBN282022/CHUSTE
- Conditions
- Cerebrospinal; Disorder
- Keywords
- Cerebrospinal compliance, Intracranial pressure., Head injury, Pulse waveform
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring
Key inclusion criteria (2 listed)
- Continuous intracranial pressure monitoring
- Sedated patient on mechanical ventilation
Key exclusion criteria (2 listed)
- Craniectomy
- Major hemodynamic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical data collectionPost-retrieval from the medical record | Other | – |
| Therapeutic data collectionPost-retrieval from the medical record | Other | – |
| IntraCranial Pression (ICP) values collectionPost-retrieval of ICP values from the monitor | Other | – |
Primary outcome
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.
1 secondary outcome
Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance
Time frame: Year : 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURENT GERGELE, MD principal investigator
CHU DE SAINT-ETIENNE
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal; Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LAURENT GERGELE, MD ((0)477828593 ext. +33, laurent.gergele@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial pressure (mmHg) (time frame: Year : 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.