Automated Robotic TCD in Traumatic Brain Injury
ConditionBrain Injuries, Traumatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18
Blunt TBI with Glasgow Coma Score (GCS) ≤8
Injury within 72 hours
Adequate TCD windows
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcranial Doppler ultrasonography (TCD)
DevicePortable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prolonged automated TCD1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 years2
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
Time frame
2 years3
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
Time frame
2 years4
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.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
Wake Forest University
Collaborator
University of California, Davis
Collaborator
Source ClinicalTrials.gov