RecruitingNCT05848297

Automated Robotic TCD in Traumatic Brain Injury

Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)


Sponsor

Virginia Commonwealth University

Enrollment

30 participants

Start Date

May 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Adults ≥18
  • Blunt TBI with Glasgow Coma Score (GCS) ≤8
  • Injury within 72 hours
  • Adequate TCD windows
  • Ability to obtain informed consent from a Legally Authorized Representative (LAR)

Exclusion Criteria6

  • Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
  • C- spine fracture with evidence of spinal cord injury
  • Severe skull or scalp injury precluding device placement
  • Planned decompressive hemicraniectomy
  • Continuous fever for >6 hours at the time of enrollment (despite treatment)
  • Lack of TCD window

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Interventions

DEVICETranscranial Doppler ultrasonography (TCD)

Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics


Locations(3)

University of California, Davis

Davis, California, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT05848297


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