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| ID | Type | Description | Link |
|---|---|---|---|
| T32HL170959 | U.S. NIH Grant/Contract | View source |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort | Experimental | The treatment cohort will undergo transcutaneous auricular nerve stimulation using an in-house 3D printed earpiece fitted with an off-the-shelf stimulation device |
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| Nontreatment Cohort | Placebo Comparator | The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Vagus Nerve Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Role of taVNS on serum CRP | Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections. | 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 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 3, Day 30 |
| Role of taVNS in surgical intervention rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC | Contact | (314) 362-5648 | zayedm@wustl.edu | |
| Kelly Koogler, RN, BSN | Contact | 3142861506 | kooglerk@wustl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38746275 | Background | Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598. | |
| 39605787 | Background | Liu FJ, Wu J, Gong LJ, Yang HS, Chen H. Non-invasive vagus nerve stimulation in anti-inflammatory therapy: mechanistic insights and future perspectives. Front Neurosci. 2024 Nov 13;18:1490300. doi: 10.3389/fnins.2024.1490300. eCollection 2024. |
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| 3D Printed Earpiece | Device | The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group. |
|
Identify the role of taVNS in surgical intervention rates |
| 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 | 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 | 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. | Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter |
| 12107680 | Background | Schillinger M, Domanovits H, Bayegan K, Holzenbein T, Grabenwoger M, Thoenissen J, Roggla M, Mullner M. C-reactive protein and mortality in patients with acute aortic disease. Intensive Care Med. 2002 Jun;28(6):740-5. doi: 10.1007/s00134-002-1299-1. Epub 2002 Apr 23. |
| 31483116 | Background | Vrsalovic M, Vrsalovic Presecki A. Admission C-reactive protein and outcomes in acute aortic dissection: a systematic review. Croat Med J. 2019 Aug 31;60(4):309-315. doi: 10.3325/cmj.2019.60.309. |
| 25133099 | Background | Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06. |
| 32001058 | Background | Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB, Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections. J Vasc Surg. 2020 Mar;71(3):723-747. doi: 10.1016/j.jvs.2019.11.013. Epub 2020 Jan 27. |