Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements (DOPPLER)

May 2, 2023 updated by: Centre Hospitalier Universitaire de la Réunion

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing planned neurosurgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 1 hour before the surgery until Day 4 post-surgery
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
From 1 hour before the surgery until Day 4 post-surgery
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)
From 1 hour before the surgery until Day 4 post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Romain ASMOLOV, MD, CHU de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Anticipated)

February 9, 2026

Study Completion (Anticipated)

June 9, 2026

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/CHU/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurological Complication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe