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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
| University of California, Davis | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged automated TCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Doppler ultrasonography (TCD) | Device | Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shraddha Mainali, MD | Contact | (804) 828-5269 | shraddha.mainali@vcuhealth.org | |
| Matthew Ridder | Contact | (804) 828-5269 | matthew.ridder@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Shraddha Mainali | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Not yet recruiting | Davis | California | 95616 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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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 |
| Wake Forest University | Not yet recruiting | Winston-Salem | North Carolina | 27109 | United States |
|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23284 | United States |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |