In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2
Low-level vagal nerve stimulation will be delivered via a clip applied to the ear throughout the surgical procedure. The voltage used will be individualized to each patient, based upon the voltage necessary to slow the sinus rate during testing.
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.
Duke University Medical Center
Durham, North Carolina, United States
Incidence/Burden of Postoperative Atrial Fibrillation
Time frame: Inpatient hospitalization approximately 3 to 7 days
Postoperative morbidity
The incidence of complications during the index hospitalization and one year after surgery
Time frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Postoperative mortality
The incidence of complications during the index hospitalization and one year after surgery
Time frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Serologic Markers of Inflammation
Cytokine levels, measured in pg/mL
Time frame: Inpatient hospitalization approximately 3 to 7 days
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