Automated robotic monitoring of blood flow in traumatic brain injury patients
Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
This study is testing if a new robotic system that monitors blood flow can safely help doctors gather important information about patients with severe brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 3 sites (Davis, California and 2 other locations) |
| Trial ID | NCT05848297 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety, feasibility, and efficacy of prolonged automated robotic transcranial Doppler (TCD) monitoring in critically ill patients suffering from severe traumatic brain injury (TBI). Participants will undergo daily monitoring sessions lasting up to 4 hours for a minimum of 3 days, utilizing a robotic TCD system that continuously records cerebral blood flow velocity in the middle cerebral artery. The study will also gather feedback from healthcare providers regarding the implementation of this monitoring protocol. The goal is to determine whether this technology can provide meaningful clinical data while ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with blunt TBI and a Glasgow Coma Score of 8 or lower, who have sustained their injury within the last 72 hours.
Not a fit: Patients with catastrophic brain injuries, severe skull injuries, or those requiring immediate surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance monitoring techniques for patients with severe TBI, potentially leading to improved patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel application of robotic TCD monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Davis, California and 2 other locations
- University of California, Davis — Davis, California, United States (Not_yet_recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Shraddha Mainali — Virginia Commonwealth University
- Study coordinator: Shraddha Mainali, MD
- Email: shraddha.mainali@vcuhealth.org
- Phone: (804) 828-5269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.