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Clinical Trials/NCT05843214
NCT05843214
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de la Réunion1 site in 1 country230 target enrollmentFebruary 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Complication
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
230
Locations
1
Primary Endpoint
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2023
End Date
June 9, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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

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

Study Sites (1)

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