Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Официальное название

The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Auricular Vagus Nerve Stimulation
  Transcutaneous auricular vagal nerve stimulation
• Устройство Sham Auricular Vagus nerve Stimulation
  Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Первичные конечные точки

• Assessment of the need for tracheostomy. [Срок оценки: 14 days]
• Occurrence of hospital-acquired infections [Срок оценки: 14 days]
• Changes in heart rate/heart trace [Срок оценки: 14 days]
• Blood glucose measurement [Срок оценки: 14 days]
• Insulin requirement [Срок оценки: 14 days]
• Hospital length of stay [Срок оценки: Through hospital admission, average 14 days]
• Neurological outcome [Срок оценки: 1 year]
• Discharge destination [Срок оценки: After hospital discharge, on average 14 days after admission.]
• Cost of ICU stay [Срок оценки: Through hospital admission, average 14 days]
• Cost of Hospital Admission [Срок оценки: Through hospital admission, average 14 days]

Вторичные конечные точки (9)

• Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma [Срок оценки: 14 days]
• Change in inflammatory markers in cerebrospinal fluid [Срок оценки: 14 days]
• Cerebral Edema [Срок оценки: 14 days]
• Neurological outcome at discharge and first follow-up [Срок оценки: up to 1 year.]
• Neurological Outcome at discharge and first follow-up [Срок оценки: up to 1 year.]
• Neurological Outcome at discharge and first follow-up [Срок оценки: Up to 1 year.]
• Neurological Outcome at discharge and first follow-up. [Срок оценки: Up to 1 year.]
• Diagnosis of hospital-acquired infections [Срок оценки: Through hospital admission, average 14 days]
• Use of a ventilator [Срок оценки: Through hospital admission, average 14 days]

Критерии участия

Критерии включения

• Age ≥18
• Admission to the NeuroICU within 36 hours of onset of an acute medical condition.
• Patient or authorized legal representative should be able to provide consent within 36 hours of ICU arrival
• Presence of at least one predictor of critical illness and/or severe brain / spinal cord injury:

• Glasgow Coma Scale GCS >3 \& <= 12 at admission
• NIH stroke scale of 6 or greater
• Requirement for ongoing mechanical ventilation
• Requirement for ongoing vasopressor support
• Diagnosis of subarachnoid hemorrhage
• Diagnosis of intracerebral hemorrhage with hematoma volume > 5 ml
• Diagnosis of moderate-severe traumatic brain injury (GCS >3 \& <= 12)
• Refractory Status epilepticus requiring continuous sedative infusions

Критерии исключения

• Systemic immunosuppression
• Receiving ongoing cancer therapy
• Implanted electrical device (e.g., pacemaker, stimulator)
• Bradycardia on admission (Sustained bradycardia on arrival with a heart rate < 50 bpm for >5 minutes)
• Risk of imminent death or limitation of care (e.g., Glasgow Coma Scale of 3, pupillary dilatation)
• Expected ICU stay of less than 72 hours, as determined by attending physician or ICU fellow
• Pregnancy
• COVID-19

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Публикации

• Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088. PMID 39786346
• Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024. PMID 39178291
• 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. PMID 38746275

Идентификаторы

NCT: NCT07219108 · 202507232

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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