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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04846738
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 100

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Brain Damage	Device: Transcranial Doppler; Device: Pupillometry.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. 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)..

2. 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

1. Mean Systolic Velocity (VMS) [At inclusion]

   Measured by Transcranial Doppler right and left.

2. Intra-Cranial Pressure (ICP) [At inclusion]

   Collect on medical file.

3. Pulsatility Index (PI) [At inclusion]

   Measured by Transcranial Doppler right and left.

4. Tele-Diastolic Velocity (TDV) [At inclusion]

   Measured by Transcranial Doppler right and left.

5. Basic pupil diameter [At inclusion]

   Measured by Pupillometry right and left

6. Percentage of variation of the pupil diameter [At inclusion]

   Measured by Pupillometry right and left

7. Latent and slope of the standard photomotor reflex [At inclusion]

   Measured by Pupillometry right and left

8. Tissue Partial Oxygen Pressure (PtiO2) [At inclusion]

   Collect on medical file.

9. Bispectral Index (BIS) [At inclusion]

   Collect on medical file. BIS is a reflection of the depth of hypnosis

10. 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.

11. Heart rate [At inclusion]

    Collect on medical file.

12. Blood pressure [At inclusion]

    Collect on medical file.

13. Natremia (mmol/l) [At inclusion]

    Collect on medical file.

14. Glycemia (mmol/l) [At inclusion]

    Collect on medical file.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: David CHARIER, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT04846738
• Other Study ID Numbers: IRBN282021/CHUSTE
• First Posted: Apr 15, 2021
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Brain injury; Transcranial Doppler; Quantitative Pupillometry,; neurological prognosis; modified Rankin Score (mRS); Glasgow Outcome Scale Extended (GOS-E)
• Additional relevant MeSH terms: Brain Injuries

Study Results

No Results Posted as of Apr 20, 2021