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

Brain Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846738
• Other study ID #: IRBN282021/CHUSTE
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: August 14, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 14, 2022
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean Systolic Velocity (VMS)	Measured by Transcranial Doppler right and left.	At inclusion
Secondary	Intra-Cranial Pressure (ICP)	Collect on medical file.	At inclusion
Secondary	Pulsatility Index (PI)	Measured by Transcranial Doppler right and left.	At inclusion
Secondary	Tele-Diastolic Velocity (TDV)	Measured by Transcranial Doppler right and left.	At inclusion
Secondary	Basic pupil diameter	Measured by Pupillometry right and left	At inclusion
Secondary	Percentage of variation of the pupil diameter	Measured by Pupillometry right and left	At inclusion
Secondary	Latent and slope of the standard photomotor reflex	Measured by Pupillometry right and left	At inclusion
Secondary	Tissue Partial Oxygen Pressure (PtiO2)	Collect on medical file.	At inclusion
Secondary	Bispectral Index (BIS)	Collect on medical file. BIS is a reflection of the depth of hypnosis	At inclusion
Secondary	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
Secondary	Heart rate	Collect on medical file.	At inclusion
Secondary	Blood pressure	Collect on medical file.	At inclusion
Secondary	Natremia (mmol/l)	Collect on medical file.	At inclusion
Secondary	Glycemia (mmol/l)	Collect on medical file.	At inclusion