Patients with uncomplicated Type B aortic dissections (TBAD) are traditionally treated in the ICU for impulse control, with BP and HR goals. Local and systemic inflammation often is a resulting consequence of acute aortic dissection. Vagus nerve stimulation can impact hemodynamics and inflammation. This study will utilize a novel transcutaneous auricular vagus nerve stimulator (taVNS) as part of the treatment for patients with TBAD. It's hypothesized that vagus nerve stimulation may provide benefit to the acute TBAD population admitted to ICU by two distinct mechanisms: 1. Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and 2. downregulation of inflammatory pathways through a neuro-immunological axis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Patients will be randomized to treatment with taVNS or placebo. The treatment cohort will undergo transcutaneous auricular vagus nerve stimulation using an in-hose 3D printed earpiece fitted with an off-the-shelf stimulation device (Soterix Medical). Stimulation will occur for 20 minutes, twice daily for 14 days or until discharge, whichever occurs first. The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.
Washington University School of Medicine
St Louis, Missouri, United States
Role of taVNS on serum CRP
Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections.
Time frame: Day 1, 3, 7, and 14 should the patient still be admitted.
Role of taVNS on dissection related end-organ deficits
Identify if in the acute period (2 weeks) following type B aortic dissections, if taVNS can change the incidence of mesenteric, renal, and limb-related ischemic events
Time frame: through study completion, an average of 1 year
Role of taVNS in mitigation of dissection propagation or evolution
Identify if taVNS utilization in the acute period (2 weeks) following type B aortic dissection can lead to a change in aortic dissection propagation based on interval CT imaging (3 days, 1 month)
Time frame: Day 3, Day 30
Role of taVNS in surgical intervention rates
Identify the role of taVNS in surgical intervention rates
Time frame: Up to 2 weeks
Role of taVNS in impulse control dosing
Volume and maximum doses of intravenous impulse control medications, including esmolol and nicardipine, across a period of up to 2 weeks
Time frame: Up to 2 weeks
Role of taVNS in ICU and hospital length of stay
Identify the role of taVNS in ICU and hospital length of stay
Time frame: Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment
Role of taVNS in the healthcare economics
Correlation between taVNS for Type B aortic dissections and total cost of care in a given hospital admission. Outcome metric is total medical costs associated with the hospital admission (dollars), to be obtained from the hospital registrar and billing services.
Time frame: Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter
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