Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU (NCT07219108) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
United States160 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with hematoma volume \> 5 ml
* Diagnosis of moderate-severe traumatic brain injury (GCS \>3 \& \<= 12)
* Refractory Status epilepticus requiring continuous sedative infusions
Exclusion Criteria:
* 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
What they're measuring
1
Assessment of the need for tracheostomy.
Timeframe: 14 days
2
Occurrence of hospital-acquired infections
Timeframe: 14 days
3
Changes in heart rate/heart trace
Timeframe: 14 days
4
Blood glucose measurement
Timeframe: 14 days
5
Insulin requirement
Timeframe: 14 days
6
Hospital length of stay
Timeframe: Through hospital admission, average 14 days
7
Neurological outcome
Timeframe: 1 year
8
Discharge destination
Timeframe: After hospital discharge, on average 14 days after admission.