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

Study Overview
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Brief Summary
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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).

Official Title
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Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit

Conditions
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Brain Damage

Intervention / Treatment
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* Device: Transcranial Doppler
* Device: Pupillometry.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All brain damaged patients (stroke or head trauma) Admitted to Intensive Care Unit since December 1, 2020 Exclusion Criteria: Refusal by the patient or his/her legal representative. Benefiting from legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| brain damaged patients<br>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<br>* This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),<br>Device: Pupillometry.<br>* This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)<br>* Other names: AlgiScan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Systolic Velocity (VMS) | Measured by Transcranial Doppler right and left. | At inclusion | 
| Intra-Cranial Pressure (ICP) | Collect on medical file. | At inclusion | 
| Pulsatility Index (PI) | Measured by Transcranial Doppler right and left. | At inclusion | 
| Tele-Diastolic Velocity (TDV) | Measured by Transcranial Doppler right and left. | At inclusion | 
| Basic pupil diameter | Measured by Pupillometry right and left | At inclusion | 
| Percentage of variation of the pupil diameter | Measured by Pupillometry right and left | At inclusion | 
| Latent and slope of the standard photomotor reflex | Measured by Pupillometry right and left | At inclusion | 
| Tissue Partial Oxygen Pressure (PtiO2) | Collect on medical file. | At inclusion | 
| Bispectral Index (BIS) | Collect on medical file. BIS is a reflection of the depth of hypnosis | At inclusion | 
| Richmond Agitation-Sedation Scale (RASS) | Richmond Agitation-Sedation Scale (RASS) is a symmetrical rating, with positive values for agitation and negative values for the level of consciousness around a point 0 corresponding to a calm and awake patient. Collect on medical file. | At inclusion | 
| Heart rate | Collect on medical file. | At inclusion | 
| Blood pressure | Collect on medical file. | At inclusion | 
| Natremia (mmol/l) | Collect on medical file. | At inclusion | 
| Glycemia (mmol/l) | Collect on medical file. | At inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain injury, Transcranial Doppler, Quantitative Pupillometry,, neurological prognosis, modified Rankin Score (mRS), Glasgow Outcome Scale Extended (GOS-E)