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

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Recruiting
CT.gov ID
NCT05843214
Collaborator
(none)
230
1
39.9
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)

Study Design

Study Type:
Observational
Anticipated Enrollment :
230 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements in Postoperative Resuscitation Neurosurgery
Actual Study Start Date :
Feb 10, 2023
Anticipated Primary Completion Date :
Feb 9, 2026
Anticipated Study Completion Date :
Jun 9, 2026

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de la Réunion Saint-Pierre Réunion 97448

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05843214
Other Study ID Numbers:
  • 2021/CHU/04
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2023