Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit
- Conditions
- Brain Damage
- Interventions
- Device: Transcranial DopplerDevice: Pupillometry.
- Registration Number
- NCT04846738
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- All brain damaged patients (stroke or head trauma)
- Admitted to Intensive Care Unit since December 1, 2020
- Refusal by the patient or his/her legal representative.
- Benefiting from legal protection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description brain damaged patients Transcranial Doppler 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. brain damaged patients Pupillometry. 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.
- Primary Outcome Measures
Name Time Method Modified Rankin Score (mRS) (0-5) Year: 1 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)..
Glasgow Outcome Scale Extended (GOS-E) (1-8) Year: 1 Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).
- Secondary Outcome Measures
Name Time Method Glycemia (mmol/l) At inclusion Collect on medical file.
Mean Systolic Velocity (VMS) At inclusion Measured by Transcranial Doppler right and left.
Intra-Cranial Pressure (ICP) At inclusion Collect on medical file.
Pulsatility Index (PI) At inclusion Measured by Transcranial Doppler right and left.
Tele-Diastolic Velocity (TDV) At inclusion Measured by Transcranial Doppler right and left.
Basic pupil diameter At inclusion Measured by Pupillometry right and left
Percentage of variation of the pupil diameter At inclusion Measured by Pupillometry right and left
Latent and slope of the standard photomotor reflex At inclusion Measured by Pupillometry right and left
Tissue Partial Oxygen Pressure (PtiO2) At inclusion Collect on medical file.
Bispectral Index (BIS) At inclusion Collect on medical file. BIS is a reflection of the depth of hypnosis
Richmond Agitation-Sedation Scale (RASS) At inclusion 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.Heart rate At inclusion Collect on medical file.
Blood pressure At inclusion Collect on medical file.
Natremia (mmol/l) At inclusion Collect on medical file.
Trial Locations
- Locations (1)
CHU Saint-Etienne
🇫🇷Saint-Étienne, France