Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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

Official Title

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

Details

Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.

Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for >= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period

Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.

Keywords

Brain Injuries, Traumatic, Brain Injuries, Traumatic Brain Injuries, Wounds and Injuries, Transcranial Doppler ultrasonography (TCD), Prolonged automated TCD

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California, Davis
    Davis California 95616 United States
  • Wake Forest University
    Winston-Salem North Carolina 27109 United States
  • Virginia Commonwealth University
    Richmond Virginia 23284 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Virginia Commonwealth University
ID
NCT05848297
Study Type
Observational
Participants
Expecting 30 study participants
Last Updated