The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction
Washington University School of Medicine
Summary
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.
Description
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 V…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 wi…
Interventions
- DeviceAuricular Vagus Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation
- DeviceSham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current/stimulation
Location
- Washington University School of MedicineSt Louis, Missouri