Automated Robotic TCD in Traumatic Brain Injury

NCT05848297 | Recruiting FDA Device

• 1 other identifier: HM20026297
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (7)

• Patient discomfort (per discretion of the bedside nurse)

  To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe

  2 years

• Inadvertent dislodgement of other intracranial monitoring device/s (if present)

  To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe

  2 years

• Skin changes associated with TCD

  To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe

  2 years

• Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.

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

  2 years

• Evaluation of adequate temporal windows

  To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe

  2 years

• Evaluation of adequate insolation of middle cerebral arteries (MCA)

  To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe

  2 years

• Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population

  A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.

  2 years

Study Arms (1)

Prolonged automated TCD

Device: Transcranial Doppler ultrasonography (TCD)

Interventions

Transcranial Doppler ultrasonography (TCD) DEVICE

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

Prolonged automated TCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe blunt head trauma with GCS ≤8 within 72 hours of brain injury will be included. Unstable patients and those without identifiable TCD windows will be excluded.

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Wake Forest University: collaborator
• University of California, Davis: collaborator

Study Sites (3)

University of California, Davis

Davis, California, 95616, United States

NOT YET RECRUITING

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

NOT YET RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Shraddha Mainali

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shraddha Mainali, MD

CONTACT

(804) 828-5269; shraddha.mainali@vcuhealth.org

Matthew Ridder

CONTACT

(804) 828-5269; matthew.ridder@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 8, 2023
• Study Start: May 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)