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NCT Number: NCT05843214

Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

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.

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Key information

Conditions

Neurological Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia BERLY, PhD

CONTACT

[email protected]

0262906286

Romain ASMOLOV, MD

CONTACT

<[email protected]>

02 62 35 90 00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: DOPPLER

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 6, 2023
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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