This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.
Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact 1) the occurrence of hospital-acquired infections, 2) the need for tracheostomy due to prolonged intubation, 3) the effect on hospital-stay physiology (e.g., vital signs and blood glucose metrics), and 4) inflammatory markers in the blood, and 5) the health economics. This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood samples for inflammatory marker analysis will be collected upon admission and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the occurrence of hospital-acquired infections, tracheostomy, changes in vital signs and blood glucose, development of peri-hematomal edema, and interventions for edema (medical or surgical). Outcomes following admission will include intensive care unit and hospital stay, cost analysis of hospital stay, discharge destination, functional scores at discharge, and at follow-up visits for up to 1 year after discharge. No additional appointments will be made specially for the research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
Transcutaneous auricular vagal nerve stimulation
Transcutaneous auricular vagal nerve ear clip applied without current/stimulation
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGAssessment of the need for tracheostomy.
Quantification of patients who need tracheostomy due to prolonged intubation.
Time frame: 14 days
Occurrence of hospital-acquired infections
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Time frame: 14 days
Changes in heart rate/heart trace
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Time frame: 14 days
Blood glucose measurement
Daily evaluation of blood glucose (mg/dL)
Time frame: 14 days
Insulin requirement
Assessment of daily insulin requirement (Units)
Time frame: 14 days
Hospital length of stay
Total length of stay in the hospital, and in the intensive care unit
Time frame: Through hospital admission, average 14 days
Neurological outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Time frame: 1 year
Discharge destination
Patient discharge destination (ie, home, acute rehab)
Time frame: After hospital discharge, on average 14 days after admission.
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Cost of ICU stay
Evaluation of total ICU cost of stay ($)
Time frame: Through hospital admission, average 14 days
Cost of Hospital Admission
Evaluation of total hospital admission cost of stay ($)
Time frame: Through hospital admission, average 14 days
Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Change in inflammatory markers in cerebrospinal fluid
rebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for TNF-α, IL-6, IL-10, and IFN-γ . Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Cerebral Edema
Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV)
Time frame: 14 days
Neurological outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Time frame: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Outcome Scale-Extended (GOSE, maximum score: 8; minimum score 1; better outcomes have higher scores).
Time frame: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Hemorrhagic stroke Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Time frame: Up to 1 year.
Neurological Outcome at discharge and first follow-up.
Disease-specific neurological outcome metric at discharge and first follow-up. National Institutes of Health Stroke Scale (NIHSS, maximum score: 42; minimum score: 1; better outcomes have lower scores).
Time frame: Up to 1 year.
Diagnosis of hospital-acquired infections
Binary assessment of hospital-acquired infections (ventilator-associated pneumonia, catheter associated urinary tract infection, Clostridium difficile infection, ventriculitis) diagnosis acquired from hospital databases. (Yes or No rating, better outcomes associated with No).
Time frame: Through hospital admission, average 14 days
Use of a ventilator
Quantification of days on ventilator
Time frame: Through hospital admission, average 14 days