HydrocephalusECHO-SDNCT03531723
Brain Ultrasound in the Weaning of External Ventricular Leads
An observational study of Hydrocephalus and Intracranial Hypertension, run by University Hospital, Toulouse at 1 site in France.
Trial summary
External Ventricular Deviation (EDV) is a medical device that provides transient and controlled external drainage of cerebrospinal fluid (CSF). This device can also monitor intracranial pressure (ICP). SEV is an emergency measure indicated for acute hydrocephalus and / or intracranial hypertension (HTIC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Intracranial Hypertension
- What is being tested?
- Measuring the size of the 3rd ventricle by ultrasound
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2018to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years-old, receiving a DVE withdrawal test and hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital
Who may be able to join
- Patient benefiting from a DVE, whatever the indication
- Hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital
- First DVE withdrawal test initiated by the doctor in charge of the patient
- Major patient
- Affiliated person or beneficiary of a social security scheme.
- Expression of non-opposition by the participant or his / her confidant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Absence of cerebral acoustic window
- Patient with a ventriculoperitoneal (DVP) diversion before the DVE.
- Antecedent surgery in the cerebral ventricular system.
- Pregnant and lactating woman
- Person under safeguard of justice
- Nosocomial neuro-meningeal infection on untreated or treatment-emergent DVE
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Timothée ABAZIOU, MD, 05 61 32 23 84 ext. 33, abaziou.t@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
External Ventricular Deviation (EDV) is a medical device that provides transient and controlled external drainage of cerebrospinal fluid (CSF). This device can also monitor intracranial pressure (ICP). SEV is an emergency measure indicated for acute hydrocephalus and / or intracranial hypertension (HTIC). Weaning from a DVE should be considered as soon as possible from the moment the patient's clinical condition allows it. There is no consensus on how to wean SEVs.
The main objective of this study is to evaluate inter and intraobserver reproducibility of the measurement of the 3rd ventricle size by ultrasound in patients receiving a DVE withdrawal test.
Read the detailed description
Ultrasound assessment of the ventricular system, including the size of the 3rd ventricle, can be used in severe traumatic brain injury. Ultrasound measurement of the size of the 3rd ventricle is used as a marker to monitor cerebral atrophy in neurodegenerative diseases such as multiple sclerosis (MS). There is good correlation between brain ultrasound and MRI and CT brain imaging to assess the size of the 3rd ventricle. Ultrasound measurement of the size of the 3rd ventricle has never been evaluated in weaning external ventricular leads.
Measuring the size of the 3rd ventricle by ultrasound could be an interesting monitoring technique during a SEV withdrawal trial to predict success or failure.
Weaning is usually based on a clamp test with more or less paraclinical clinical monitoring. The recurrence of hydrocephalus and / or HTIC defines a withdrawal failure of the drainage device.
The size of the 3rd ventricle evaluated by cerebral CT in a clamp test is found as a predictor of weaning failure of a DVE.
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Being tested
- Measuring the size of the 3rd ventricle by ultrasound
- Keywords
- external ventricular derivation
- Medical subject headings
- Hydrocephalus, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring the size of the 3rd ventricle by ultrasoundOther
The surveillance of the clamping test is essentially clinical. No cerebral imaging is performed systematically in our service protocol.The study consisted of including ultrasound measurements during the usual weaning protocol of the service.All patients receiving a SEV withdrawal test will be included. Inclusion begins when the clinician in charge of the patient initiates the withdrawal test. The measurements will be performed blindly by a trained physician who does not participate in the patient's care. Four measurements will be made, with recording of ultrasound loops
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The inter-individual reproducibility will be evaluated at each time by the analysis of a loop by 3 independent and blind operators.
The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
Measured: 3 weeks
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The intra-individual reproducibility will be evaluated at each time by the acquisition of 3 ultrasound loops analyzed by the same operator.
The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
Measured: 3 weeks
Secondary outcomes (4)
Measurement of the evolution of the size of the 3rd ventricle (intra individual)
Intra individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle
Measured: 3 weeks
Measurement of the evolution of the size of the 3rd ventricle (inter individual)
Inter individual reproducibility of the ultrasound measurement of the evolution of the size of the 3rd ventricle
Measured: 3 weeks
Successful completion of the DVE withdrawal test
Successful completion of the DVE withdrawal test, defined by the absence of the need to decline or rest a DVE at 3 weeks.
Measured: 3 weeks
Failure of the weaning test
Failure of the weaning test defined by the need to decline or rest a DVE at 3 weeks.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start12 Jul 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothée ABAZIOU, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531723
- Sponsor's protocol ID
- RC31/18/0178
- Other IDs
- 2018-A01219-46
- Acronym
- ECHO-SD
- Status last verified
- Jul 2018
- First submitted
- 9 May 2018
- Last updated
- 23 Jul 2018
- 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 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Ultrasound in the Weaning of External Ventricular Leads
- ClinicalTrials.gov ID
- NCT03531723
- Acronym / sponsor ID
- ECHO-SD / RC31/18/0178
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Keywords
- external ventricular derivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 22 May 2018 (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.
External Ventricular Deviation (EDV) is a medical device that provides transient and controlled external drainage of cerebrospinal fluid (CSF). This device can also monitor intracranial pressure (ICP). SEV is an emergency measure indicated for acute hydrocephalus and / or intracranial hypertension (HTIC). Weaning from a DVE should be considered as soon as possible from the moment the patient's clinical condition allows it. There is no consensus on how to wean SEVs.
The main objective of this study is to evaluate inter and intraobserver reproducibility of the measurement of the 3rd ventricle size by ultrasound in patients receiving a DVE withdrawal test.
Detailed description
Ultrasound assessment of the ventricular system, including the size of the 3rd ventricle, can be used in severe traumatic brain injury. Ultrasound measurement of the size of the 3rd ventricle is used as a marker to monitor cerebral atrophy in neurodegenerative diseases such as multiple sclerosis (MS). There is good correlation between brain ultrasound and MRI and CT brain imaging to assess the size of the 3rd ventricle. Ultrasound measurement of the size of the 3rd ventricle has never been evaluated in weaning external ventricular leads.
Measuring the size of the 3rd ventricle by ultrasound could be an interesting monitoring technique during a SEV withdrawal trial to predict success or failure.
Weaning is usually based on a clamp test with more or less paraclinical clinical monitoring. The recurrence of hydrocephalus and / or HTIC defines a withdrawal failure of the drainage device.
The size of the 3rd ventricle evaluated by cerebral CT in a clamp test is found as a predictor of weaning failure of a DVE.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years-old, receiving a DVE withdrawal test and hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital
Key inclusion criteria (6 listed)
- Patient benefiting from a DVE, whatever the indication
- Hospitalized in the neurosurgical resuscitation and neurosurgical intensive care units of Toulouse University Hospital
- First DVE withdrawal test initiated by the doctor in charge of the patient
- Major patient
- Affiliated person or beneficiary of a social security scheme.
Key exclusion criteria (6 listed)
- Absence of cerebral acoustic window
- Patient with a ventriculoperitoneal (DVP) diversion before the DVE.
- Antecedent surgery in the cerebral ventricular system.
- Pregnant and lactating woman
- Person under safeguard of justice
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 |
|---|---|---|
| Measuring the size of the 3rd ventricle by ultrasoundThe surveillance of the clamping test is essentially clinical. No cerebral imaging is performed systematically in our service protocol.The study consisted of including ultrasound measurements during the usual weaning protocol of the service.All patients receiving a SEV withdrawal test will be included. Inclusion begins when the clinician in charge of the patient initiates the withdrawal test. The measurements will be performed blindly by a trained physician who does not participate in the patient's care. Four measurements will be made, with recording of ultrasound loops | Other | – |
Primary outcome
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
Time frame: 3 weeks
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The inter-individual reproducibility will be evaluated at each time by the analysis of a loop by 3 independent and blind operators. The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle
Time frame: 3 weeks
Intra individual reproducibility of ultrasound measurement of the size of the 3rd ventricle at different study times The intra-individual reproducibility will be evaluated at each time by the acquisition of 3 ultrasound loops analyzed by the same operator. The analysis of all ultrasound loop recordings will be performed at the end of the participation of the last included patient. The recordings of the ultrasound loops will be coded and presented in a random and different order to each operator.
4 secondary outcomes
Measurement of the evolution of the size of the 3rd ventricle (intra individual)
Time frame: 3 weeks
Measurement of the evolution of the size of the 3rd ventricle (inter individual)
Time frame: 3 weeks
Successful completion of the DVE withdrawal test
Time frame: 3 weeks
Failure of the weaning test
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- 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.
Timothée ABAZIOU, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Intracranial Hypertension, run by University Hospital, Toulouse at 1 site 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 6 inclusion and 6 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Timothée ABAZIOU, MD (05 61 32 23 84 ext. 33, abaziou.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter individual reproducibility of ultrasound measurement of the size of the 3rd ventricle (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 23 Jul 2018.