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Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements in Postoperative Resuscitation Neurosurgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05843214
Acronym
DOPPLER
Enrollment
230
Registered
2023-05-06
Start date
2023-02-10
Completion date
2027-12-31
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Complication

Brief 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.

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

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)From 1 hour before the surgery until Day 4 post-surgeryThis 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)From 1 hour before the surgery until Day 4 post-surgeryThe diameter of the optic nerve envelope will be collected bilaterally using an ultrasound machine
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)From 1 hour before the surgery until Day 4 post-surgeryThe 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)

Countries

Reunion

Contacts

CONTACTRomain ASMOLOV, MD
<romain.asmolov@chu-reunion.fr>02 62 35 90 00
CONTACTLaetitia BERLY, PhD
laetitia.berly@chu-reunion.fr0262906286
PRINCIPAL_INVESTIGATORRomain ASMOLOV, MD

CHU de la Réunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026