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NCT Number: NCT05848297

Automated Robotic TCD in Traumatic Brain Injury

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis, Davis, California, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler ultrasonography (TCD)

Device

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

Primary outcomes

  1. Patient discomfort (per discretion of the bedside nurse)

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  3. Skin changes associated with TCD

    Time frame: 2 years

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

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

    Time frame: 2 years

    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.

  5. Evaluation of adequate temporal windows

    Time frame: 2 years

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

  6. Evaluation of adequate insolation of middle cerebral arteries (MCA)

    Time frame: 2 years

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

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

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Ridder

CONTACT

[email protected]

(804) 828-5269

Shraddha Mainali, MD

CONTACT

[email protected]

(804) 828-5269

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • University of California, Davis
  • Wake Forest University

Registry information

Official study title

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

Acronym: ART-TBI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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