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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Device: Transcranial Doppler ultrasonography (TCD)

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Shraddha Mainali, MD; Phone Number: (804) 828-5269; Email: shraddha.mainali@vcuhealth.org
• Study Contact Backup: Name: Matthew Ridder; Phone Number: (804) 828-5269; Email: matthew.ridder@vcuhealth.org

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis
      • Contact: Jeffrey Robert Vitt, MD; Email: jrvitt@ucdavis.edu
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest University
      • Contact: Aarti Sarwal, MD; Email: asarwal@wakehealth.edu
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University
      • Contact: Shraddha Mainali, MD; Phone Number: 804-828-5269; Email: Shraddha.Mainali@vcuhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prolonged automated TCD	Device: Transcranial Doppler ultrasonography (TCD); Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: University of California, Davis; Wake Forest University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HM20026297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No