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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04846738
Enrollment
73
Registered
2021-04-15
Start date
2021-04-01
Completion date
2022-08-14
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Damage

Keywords

Brain injury, Transcranial Doppler, Quantitative Pupillometry,, neurological prognosis, modified Rankin Score (mRS), Glasgow Outcome Scale Extended (GOS-E)

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).

Interventions

DEVICETranscranial Doppler

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

DEVICEPupillometry.

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Score (mRS) (0-5)Year: 1Modified 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: 1Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).

Secondary

MeasureTime frameDescription
Tissue Partial Oxygen Pressure (PtiO2)At inclusionCollect on medical file.
Bispectral Index (BIS)At inclusionCollect on medical file. BIS is a reflection of the depth of hypnosis
Basic pupil diameterAt inclusionMeasured by Pupillometry right and left
Mean Systolic Velocity (VMS)At inclusionMeasured by Transcranial Doppler right and left.
Intra-Cranial Pressure (ICP)At inclusionCollect on medical file.
Pulsatility Index (PI)At inclusionMeasured by Transcranial Doppler right and left.
Percentage of variation of the pupil diameterAt inclusionMeasured by Pupillometry right and left
Richmond Agitation-Sedation Scale (RASS)At inclusionRichmond 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 rateAt inclusionCollect on medical file.
Blood pressureAt inclusionCollect on medical file.
Natremia (mmol/l)At inclusionCollect on medical file.
Glycemia (mmol/l)At inclusionCollect on medical file.
Tele-Diastolic Velocity (TDV)At inclusionMeasured by Transcranial Doppler right and left.
Latent and slope of the standard photomotor reflexAt inclusionMeasured by Pupillometry right and left

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026