Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

NCT ID: NCT05843214

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-10

Study Completion Date

2026-06-09

Brief Summary

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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.

Detailed Description

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Conditions

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Neurological Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romain ASMOLOV, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Réunion

Locations

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CHU de la Réunion

Saint-Pierre, , Reunion

Site Status RECRUITING

Countries

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Reunion

Central Contacts

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Romain ASMOLOV, MD

Role: CONTACT

02 62 35 90 00

Laetitia BERLY, PhD

Role: CONTACT

0262906286

Facility Contacts

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Romain ASMOLOV, MD

Role: primary

02 62 35 90 00

Other Identifiers

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2021/CHU/04

Identifier Type: -

Identifier Source: org_study_id

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