Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

Neurological Complication Clinical Trial

— DOPPLER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843214
• Other study ID #: 2021/CHU/04
• Status: Recruiting
• Start date: February 10, 2023
• Est. completion date: June 9, 2026

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Romain ASMOLOV, MD
• Phone: 02 62 35 90 00
• Email: [@]chu-reunion.fr>
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 9, 2026
• Est. primary completion date: February 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurological Complication

Intervention

Other:
• Non-invasive neuromonitoring evaluation (transcranial doppler, optic nerve envelope diameter and quantitative pupillometry)
4 days Post-operation follow-up. Data will be gathered before the surgery and at regular times after the surgery until day 4

Locations

Country	Name	City	State
Réunion	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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