Neuro-intensive Care Unit PatientsECHO-V3NCT02830269
Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
An observational study of Neuro-intensive Care Unit Patients and Brain Injuries, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuro-intensive Care Unit Patients, Brain Injuries
- What is being tested?
- Transcranial Doppler ultrasonography measurements
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2016to 16 May 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the neurointensive care
Who may be able to join
- Adult, > or equal to 18-yr
- Admission to neuro-intensive care unit with brain injury
- Evaluation by Computer Tomography
- Indication for Transcranial Doppler ultrasonography
Who cannot join
- Opposition to participate by the patient or a next of kin
Trial locations and contacts
1 site in 1 country.
About this study
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).
Read the detailed description
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler
- Conditions
- Neuro-intensive Care Unit Patients, Brain Injuries
- Being tested
- Transcranial Doppler ultrasonography measurements
- Keywords
- Neuro-ICU, Third ventricle, Computer Tomography, Transcranial Doppler ultrasonography
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler ultrasonography measurementsDevice
Third ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Third ventricle diameter (average +/- standard deviation)
Spearman's test measuring the correlation coefficient between the third ventricle diameter measured by the expert using the ultrasonography and the third ventricle diameter measured by CT scan.
Measured: Through study completion (30 months)
Secondary outcomes (1)
Residents' learning curve
The learning curve will be determined by the change in the third ventricle diameter's difference obtained by the expert and the resident, divided by the diameter obtained by the expert reported on the Y-axis and the number of measures done by the resident reported on the X-axis. Number of measures to be done will be determined when the curve reached the zero.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start18 Aug 2016
- Primary completion16 May 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuro-intensive Care Unit PatientsStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GERALD CHANQUES, MD, Ph D, Study director, University Hospital, MontpellierPierre-François PERRIGAULT, MD, Study chair, University Hospital, MontpellierPaul BORY, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830269
- Sponsor's protocol ID
- 9720
- Other IDs
- 2016-A00749-42
- Acronym
- ECHO-V3
- Status last verified
- Apr 2017
- First submitted
- 10 Jun 2016
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Widehem R, Bory P, Greco F, Pavillard F, Chalard K, Mas A, Djanikian F, Carr J, Molinari N, Jaber S, Perrigault PF, Chanques G. Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study. Ann Intensive Care. 2021 May 4;11(1):69. doi: 10.1186/s13613-021-00857-x.
PubMed 33945045
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT02830269
- Acronym / sponsor ID
- ECHO-V3 / 9720
- Conditions
- Neuro-intensive Care Unit Patients, Brain Injuries
- Keywords
- Neuro-ICU, Third ventricle, Computer Tomography, Transcranial Doppler ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).
Detailed description
Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the neurointensive care
Key inclusion criteria (4 listed)
- Adult, > or equal to 18-yr
- Admission to neuro-intensive care unit with brain injury
- Evaluation by Computer Tomography
- Indication for Transcranial Doppler ultrasonography
Key exclusion criteria (1 listed)
- Opposition to participate by the patient or a next of kin
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 |
|---|---|---|
| Transcranial Doppler ultrasonography measurementsThird ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography | Device | – |
Primary outcome
Third ventricle diameter (average +/- standard deviation)
Time frame: Through study completion (30 months)
Spearman's test measuring the correlation coefficient between the third ventricle diameter measured by the expert using the ultrasonography and the third ventricle diameter measured by CT scan.
1 secondary outcome
Residents' learning curve
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Derived from this study: PubMed 33945045Widehem R, Bory P, Greco F, Pavillard F, Chalard K, Mas A, Djanikian F, Carr J, Molinari N, Jaber S, Perrigault PF, Chanques G. Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study. Ann Intensive Care. 2021 May 4;11(1):69. doi: 10.1186/s13613-021-00857-x.
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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.
GERALD CHANQUES, MD, Ph D study director
University Hospital, Montpellier
Pierre-François PERRIGAULT, MD study chair
University Hospital, Montpellier
Paul BORY, MD principal investigator
University Hospital, Montpellier
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 Neuro-intensive Care Unit Patients and Brain Injuries, run by University Hospital, Montpellier 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 5 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Third ventricle diameter (average +/- standard deviation) (time frame: Through study completion (30 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830269, which also lists 1 linked publication.
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 Dec 2018.