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

NCT ID: NCT04846738

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-08-14

Brief Summary

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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

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Conditions

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Brain Damage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Transcranial Doppler

Intervention Type DEVICE

This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),

Pupillometry.

Intervention Type DEVICE

This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)

Interventions

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Transcranial Doppler

This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),

Intervention Type DEVICE

Pupillometry.

This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)

Intervention Type DEVICE

Other Intervention Names

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AlgiScan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David CHARIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN282021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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