Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

Recruiting

• Conditions: Neurological Complication

• Registration Number: NCT05843214
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2026-02-09
• Study Completion: 2026-06-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)	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)
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)	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)	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

Trial Locations

Locations (1)

CHU de la Réunion; 🇷🇪 Saint-Pierre, Réunion