Skip to main content
Clinical Trials/NCT04846738
NCT04846738
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country73 target enrollmentApril 1, 2021
ConditionsBrain Damage

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Damage
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
73
Locations
1
Primary Endpoint
Modified Rankin Score (mRS) (0-5)
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
August 14, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)..

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

  • Mean Systolic Velocity (VMS)(At inclusion)
  • Intra-Cranial Pressure (ICP)(At inclusion)
  • Pulsatility Index (PI)(At inclusion)
  • Tele-Diastolic Velocity (TDV)(At inclusion)
  • Basic pupil diameter(At inclusion)
  • Percentage of variation of the pupil diameter(At inclusion)
  • Latent and slope of the standard photomotor reflex(At inclusion)
  • Tissue Partial Oxygen Pressure (PtiO2)(At inclusion)
  • Bispectral Index (BIS)(At inclusion)
  • Richmond Agitation-Sedation Scale (RASS)(At inclusion)
  • Heart rate(At inclusion)
  • Blood pressure(At inclusion)
  • Natremia (mmol/l)(At inclusion)
  • Glycemia (mmol/l)(At inclusion)

Study Sites (1)

Loading locations...

Similar Trials