Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Glasgow Coma Scale GCS >3 & <= 12 at admission
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Auricular Vagus Nerve Stimulation
DeviceTranscutaneous auricular vagal nerve stimulation
Sham Auricular Vagus nerve Stimulation
DeviceTranscutaneous auricular vagal nerve ear clip applied without current/stimulation
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Auricular VNS StimulationExperimental treatment 1 intervention
Group B: Sham Auricular VNS StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of the need for tracheostomy.
Quantification of patients who need tracheostomy due to prolonged intubation.
Time frame
14 days2
Occurrence of hospital-acquired infections
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Time frame
14 days3
Changes in heart rate/heart trace
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Time frame
14 days4
Blood glucose measurement
Daily evaluation of blood glucose (mg/dL)
Time frame
14 daysSecondary outcomes
1
Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Time frame
14 days2
Change in inflammatory markers in cerebrospinal fluid
rebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for TNF-α, IL-6, IL-10, and IFN-γ . Inflammatory markers will be reported in pg/mL.
Time frame
14 days3
Cerebral Edema
Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV)
Time frame
14 days4
Neurological outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Time frame
up to 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov