Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit

NCT04846738 | Completed

• 1 other identifier: IRBN282021/CHUSTE
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).

Conditions

Brain Damage

Keywords

Brain injury; Transcranial Doppler; Quantitative Pupillometry,; neurological prognosis; modified Rankin Score (mRS); Glasgow Outcome Scale Extended (GOS-E)

Outcome Measures

Primary Outcomes (2)

• Modified Rankin Score (mRS) (0-5)

  Modified Rankin Score (mRS) measures the degree of disability following a stroke in a patient (level 0 for patients with no symptoms to level 5 for patients with major disability and total dependency)..

  Year: 1

• Glasgow Outcome Scale Extended (GOS-E) (1-8)

  Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).

  Year: 1

Secondary Outcomes (14)

• Mean Systolic Velocity (VMS)

  At inclusion

• Intra-Cranial Pressure (ICP)

  At inclusion

• Pulsatility Index (PI)

  At inclusion

• Tele-Diastolic Velocity (TDV)

  At inclusion

• Basic pupil diameter

  At inclusion

Study Arms (1)

brain damaged patients

All major brain damaged patients (stroke or head trauma) admitted to reanimation will be included. In the usual practice, they have a Transcranial Doppler and the measurement of the photomotor reflex by quantitative Pupillometry. It is planned to collect the simultaneous values of the different parameters during 2,000 measurements. The data will be collected retrospectively from 01/12/2020, and prospectively from 01/04/2021.

Device: Transcranial Doppler; Device: Pupillometry.

Interventions

Transcranial Doppler DEVICE

This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),

brain damaged patients

Pupillometry. DEVICE

This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)

Also known as: AlgiScan

brain damaged patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All brain damaged patients (stroke or head trauma), admitted to Intensive Care Unit since December 1, 2020

You may qualify if:

• All brain damaged patients (stroke or head trauma)
• Admitted to Intensive Care Unit since December 1, 2020

You may not qualify if:

• Refusal by the patient or his/her legal representative.
• Benefiting from legal protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• David CHARIER, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: April 1, 2021
• Primary Completion: July 14, 2021
• Study Completion: August 14, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)