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

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Damage
• Intervention / Treatment: Device: Transcranial Doppler; Device: Pupillometry.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),; Device: Pupillometry.; This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex); Other Names: AlgiScan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): August 14, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Brain injury; Transcranial Doppler; Quantitative Pupillometry,; neurological prognosis; modified Rankin Score (mRS); Glasgow Outcome Scale Extended (GOS-E)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: IRBN282021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No