Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
This study is testing if transcutaneous auricular vagus nerve stimulation (taVNS) can help patients in the NeuroICU recover better. taVNS involves a device that stimulates a nerve in your ear. We want to see if taVNS can reduce hospital-acquired infections, decrease the need for a breathing tube (tracheostomy), and improve vital signs like heart rate. We are also looking at the economic benefits. You might be able to join if you are 18 or older, admitted to the NeuroICU within 36 hours for an acute medical condition, and have certain signs of critical illness or brain/spinal cord injury. The study aims to enroll 160 participants. The current recruitment status is unclear.
- Study design
- This interventional study will involve randomly assigning participants to receive either transcutaneous auricular vagal nerve stimulation or a sham (inactive) stimulation.
- What's involved
- Blood samples will be collected upon admission and throughout your hospital stay. Clinical events like infections, tracheostomy, and changes in vital signs will be tracked during your hospital stay. No additional appointments will be made specifically for this research study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Outcomes will be tracked during your hospital stay, at discharge, and at follow-up visits for up to 1 year after discharge.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Eric Leuthardt, MD MBA · STUDY_CHAIR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Assessment of the need for tracheostomy.14 days
Quantification of patients who need tracheostomy due to prolonged intubation.
- Occurrence of hospital-acquired infections14 days
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
- Changes in heart rate/heart trace14 days
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
- Blood glucose measurement14 days
Daily evaluation of blood glucose (mg/dL)
- Insulin requirement14 days
Assessment of daily insulin requirement (Units)
- Hospital length of stayThrough hospital admission, average 14 days
Total length of stay in the hospital, and in the intensive care unit
- Neurological outcome1 year
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
- Discharge destinationAfter hospital discharge, on average 14 days after admission.
Patient discharge destination (ie, home, acute rehab)
- Cost of ICU stayThrough hospital admission, average 14 days
Evaluation of total ICU cost of stay ($)
- Cost of Hospital AdmissionThrough hospital admission, average 14 days
Evaluation of total hospital admission cost of stay ($)