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NCT Number: NCT04846738

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

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).

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Key information

Conditions

Brain Damage Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler

Device

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

Pupillometry.

Device

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

Other names: AlgiScan

Primary outcomes

  1. Modified Rankin Score (mRS) (0-5)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Mean Systolic Velocity (VMS)

    Time frame: At inclusion

    Measured by Transcranial Doppler right and left.

  2. Intra-Cranial Pressure (ICP)

    Time frame: At inclusion

    Collect on medical file.

  3. Pulsatility Index (PI)

    Time frame: At inclusion

    Measured by Transcranial Doppler right and left.

  4. Tele-Diastolic Velocity (TDV)

    Time frame: At inclusion

    Measured by Transcranial Doppler right and left.

  5. Basic pupil diameter

    Time frame: At inclusion

    Measured by Pupillometry right and left

  6. Percentage of variation of the pupil diameter

    Time frame: At inclusion

    Measured by Pupillometry right and left

  7. Latent and slope of the standard photomotor reflex

    Time frame: At inclusion

    Measured by Pupillometry right and left

  8. Tissue Partial Oxygen Pressure (PtiO2)

    Time frame: At inclusion

    Collect on medical file.

  9. Bispectral Index (BIS)

    Time frame: At inclusion

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

  10. Richmond Agitation-Sedation Scale (RASS)

    Time frame: 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

    Time frame: At inclusion

    Collect on medical file.

  12. Blood pressure

    Time frame: At inclusion

    Collect on medical file.

  13. Natremia (mmol/l)

    Time frame: At inclusion

    Collect on medical file.

  14. Glycemia (mmol/l)

    Time frame: At inclusion

    Collect on medical file.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 15, 2021
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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