Brain Injuries, Traumatic
Conditions
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.
Interventions
Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics
Sponsors
Virginia Commonwealth University
Wake Forest University
University of California, Davis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient discomfort (per discretion of the bedside nurse) | 2 years | To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe |
| Inadvertent dislodgement of other intracranial monitoring device/s (if present) | 2 years | To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe |
| Skin changes associated with TCD | 2 years | To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe |
| Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population. | 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. |
| Evaluation of adequate temporal windows | 2 years | To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe |
| Evaluation of adequate insolation of middle cerebral arteries (MCA) | 2 years | To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe |
| Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population | 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. |
Countries
United States
Contacts
CONTACTShraddha Mainali, MD
CONTACTMatthew Ridder
PRINCIPAL_INVESTIGATORShraddha Mainali
Virginia Commonwealth University
Outcome results
None listed