Neurological ComplicationDOPPLERNCT05843214
Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements
An observational study of Neurological Complication, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
Non-invasive neuromonitoring tools such as transcranial doppler, optic nerve envelope diameter measurement and quantitative pupillometry are routinely used in acute brain injured patients as part of multimodal neuromonitoring with the aim, among others, of detecting episodes of intracranial hypertension, each method… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Complication
- What is being tested?
- Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)
- How many people
- 230 participants
- Where
- 1 siteReunion
- Study dates
- 10 Feb 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing planned neurosurgery
Who may be able to join
- Regulated intracranial surgery: scheduled > 48 hours
- French-speaking patient
- No opposition from the patient or a relative when the patient is unable to consent
Who cannot join
- Chronic subdural haematoma
- Isolated cerebral endovascular procedure
- Stereotactic biopsy
- Scheduled ventriculoperitoneal shunt or isolated ventriculocisternostomy
- Specific non-inclusion criteria for quantitative pupillometry: known pupillary abnormalities, glaucoma, cataract surgery and any ocular surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion1 site, 1 recruiting
- Recruiting
CHU de la Réunion
Saint-Pierre, 97448
Romain ASMOLOV, MD, 02 62 35 90 00, romain.asmolov@chu-reunion.fr
About this study
Official title: Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements in Postoperative Resuscitation Neurosurgery
Non-invasive neuromonitoring tools such as transcranial doppler, optic nerve envelope diameter measurement and quantitative pupillometry are routinely used in acute brain injured patients as part of multimodal neuromonitoring with the aim, among others, of detecting episodes of intracranial hypertension, each method allowing the study of one of the different pathophysiological mechanisms of its impact.
However, at present there is no data in the literature on the value of these non-invasive neuromonitoring tools in the management of patients undergoing controlled intracranial surgery.
The study aims to help the early detection of postoperative neurological deterioration.
- Conditions
- Neurological Complication
- Being tested
- Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)Other
4 days Post-operation follow-up. Data will be gathered before the surgery and at regular times after the surgery until day 4
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)
This emasure will be performed bilaterally at the level of the first part of the middle cerebral artery, the values collected will be:
- Systolic, mean and diastolic velocities; pulsatility index
- Estimation of intracranial pressure
Measured: From 1 hour before the surgery until Day 4 post-surgery
Evolution of non-invasive neuromonitoring measures (optic nerve envelope diameter)
The diameter of the optic nerve envelope will be collected bilaterally using an ultrasound machine
Measured: From 1 hour before the surgery until Day 4 post-surgery
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)
The values collected will be :
- Size, quantification of the amplitude of variation to light, latency and speed of constriction of the pupil, presence or absence of anisocoria (defined by a difference >1mm in size between the two pupils)
Measured: From 1 hour before the surgery until Day 4 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start10 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ComplicationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain ASMOLOV, MD, Principal investigator, CHU de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843214
- Sponsor's protocol ID
- 2021/CHU/04
- Acronym
- DOPPLER
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2023
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements in Postoperative Resuscitation Neurosurgery
- ClinicalTrials.gov ID
- NCT05843214
- Acronym / sponsor ID
- DOPPLER / 2021/CHU/04
- Conditions
- Neurological Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 2023 (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.
Non-invasive neuromonitoring tools such as transcranial doppler, optic nerve envelope diameter measurement and quantitative pupillometry are routinely used in acute brain injured patients as part of multimodal neuromonitoring with the aim, among others, of detecting episodes of intracranial hypertension, each method allowing the study of one of the different pathophysiological mechanisms of its impact.
However, at present there is no data in the literature on the value of these non-invasive neuromonitoring tools in the management of patients undergoing controlled intracranial surgery.
The study aims to help the early detection of postoperative neurological deterioration.
Study design
- Observational model
- Case only
- 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 undergoing planned neurosurgery
Key inclusion criteria (3 listed)
- Regulated intracranial surgery: scheduled > 48 hours
- French-speaking patient
- No opposition from the patient or a relative when the patient is unable to consent
Key exclusion criteria (5 listed)
- Chronic subdural haematoma
- Isolated cerebral endovascular procedure
- Stereotactic biopsy
- Scheduled ventriculoperitoneal shunt or isolated ventriculocisternostomy
- Specific non-inclusion criteria for quantitative pupillometry: known pupillary abnormalities, glaucoma, cataract surgery and any ocular surgery.
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 |
|---|---|---|
| Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)4 days Post-operation follow-up. Data will be gathered before the surgery and at regular times after the surgery until day 4 | Other | – |
Primary outcome
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)
Time frame: From 1 hour before the surgery until Day 4 post-surgery
This emasure will be performed bilaterally at the level of the first part of the middle cerebral artery, the values collected will be: * Systolic, mean and diastolic velocities; pulsatility index * Estimation of intracranial pressure
Evolution of non-invasive neuromonitoring measures (optic nerve envelope diameter)
Time frame: From 1 hour before the surgery until Day 4 post-surgery
The diameter of the optic nerve envelope will be collected bilaterally using an ultrasound machine
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)
Time frame: From 1 hour before the surgery until Day 4 post-surgery
The values collected will be : - Size, quantification of the amplitude of variation to light, latency and speed of constriction of the pupil, presence or absence of anisocoria (defined by a difference >1mm in size between the two pupils)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
Romain ASMOLOV, MD principal investigator
CHU de la Réunion
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 Neurological Complication, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 Reunion. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain ASMOLOV, MD (02 62 35 90 00, <romain.asmolov@chu-reunion.fr>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of non-invasive neuromonitoring measures (using transcranial doppler) (time frame: From 1 hour before the surgery until Day 4 post-surgery). The study lists 3 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 11 Sep 2026.