Clinical trial NCT05848297: Automated Robotic TCD in Traumatic Brain Injury
Official title: Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries, Traumatic
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: University of California, Davis
First posted: 2023-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Patient discomfort (per discretion of the bedside nurse)
timeFrame: 2 years
measure: Inadvertent dislodgement of other intracranial monitoring device/s (if present)
timeFrame: 2 years
measure: Skin changes associated with TCD
timeFrame: 2 years
measure: Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.
timeFrame: 2 years
measure: Evaluation of adequate temporal windows
timeFrame: 2 years
measure: Evaluation of adequate insolation of middle cerebral arteries (MCA)
timeFrame: 2 years
measure: Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Shraddha Mainali
role: PRINCIPAL_INVESTIGATOR
References: