NCT05848297

Automated Robotic TCD in Traumatic Brain Injury

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Detailed 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.

Conditions

• Brain Injuries, Traumatic

Interventions

Type	Name	Description
DEVICE	Transcranial Doppler ultrasonography (TCD)	Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-05-08
• Last updated: 2025-10-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study