Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements
DOPPLER
1 other identifier
observational
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2026
ExpectedMay 6, 2023
April 1, 2023
3 years
April 11, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Evolution of non-invasive neuromonitoring measures (using transcranial doppler)
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
From 1 hour before the surgery until Day 4 post-surgery
Evolution of non-invasive neuromonitoring measures (optic nerve envelope diameter)
The diameter of the optic nerve envelope will be collected bilaterally using an ultrasound machine
From 1 hour before the surgery until Day 4 post-surgery
Evolution of non-invasive neuromonitoring measures (quantitative pupillometry)
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)
From 1 hour before the surgery until Day 4 post-surgery
Interventions
4 days Post-operation follow-up. Data will be gathered before the surgery and at regular times after the surgery until day 4
Eligibility Criteria
Patients undergoing planned neurosurgery
You may qualify if:
- Regulated intracranial surgery: scheduled \> 48 hours
- French-speaking patient
- No opposition from the patient or a relative when the patient is unable to consent
You may not qualify if:
- Chronic subdural haematoma
- Isolated cerebral endovascular procedure
- Stereotactic biopsy
- Scheduled ventriculoperitoneal shunt or isolated ventriculocisternostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de la Réunion
Saint-Pierre, 97448, Reunion
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romain ASMOLOV, MD
CHU de la Réunion
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2023
First Posted
May 6, 2023
Study Start
February 10, 2023
Primary Completion
February 9, 2026
Study Completion (Estimated)
June 9, 2026
Last Updated
May 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share