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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Brain Injuries, Traumatic

Treatments: Device: Transcranial Doppler ultrasonography (TCD)

Study type: Observational

Funder types: Other

Identifiers

NCT05848297

HM20026297

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

30 participants in 1 patient group

Prolonged automated TCD

Treatment:

Device: Transcranial Doppler ultrasonography (TCD)