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RecruitingNCT05843214DOPPLERUpdated Sep 11, 2026

Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

An observational study in Neurological Complication, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 1 site in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
230
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neurological Complication
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing planned neurosurgery

Inclusion criteria

  • Regulated intracranial surgery: scheduled > 48 hours
  • French-speaking patient
  • No opposition from the patient or a relative when the patient is unable to consent

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
230 participants (estimated)
Patient registry
No

Interventions

  • OtherNon-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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: From 1 hour before the surgery until Day 4 post-surgery

  2. 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

    Time frame: From 1 hour before the surgery until Day 4 post-surgery

  3. 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)

    Time frame: From 1 hour before the surgery until Day 4 post-surgery

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT05843214
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Feb 10, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Romain ASMOLOV, MD
Contact
<romain.asmolov@chu-reunion.fr>
02 62 35 90 00
Laetitia BERLY, PhD
Contact
laetitia.berly@chu-reunion.fr
0262906286
Romain ASMOLOV, MD
principal investigator · CHU de la Réunion

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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