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

Completed

• Conditions: Brain Damage

• Registration Number: NCT04846738
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-15
• Primary Completion: 2021-07-14
• Study Completion: 2022-08-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.
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.
Intra-Cranial Pressure (ICP)	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