Atrial Fibrillation, Postoperative, Inflammation, Postoperative Complications
Conditions
Keywords
Autonomic, Vagal nerve stimulation, Postoperative atrial fibrillation
Brief summary
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.
Interventions
DEVICETranscutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
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.
DEVICESham LLVNS
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)
Exclusion criteria
* Patients \>90 or \<40 years of age * Chronic atrial fibrillation * Prior splenectomy * Preoperative inotropic support * Hepatic or renal failure * Currently receiving vagal nerve stimulation therapy * Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine) * High-grade atrioventricular block (\>2nd degree atrioventricular blockade)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence/Burden of Postoperative Atrial Fibrillation | Inpatient hospitalization approximately 3 to 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serologic Markers of Inflammation | Inpatient hospitalization approximately 3 to 7 days | Cytokine levels, measured in pg/mL |
| Postoperative morbidity | Inpatient hospitalization approximately 3 to 7 days, and one year after surgery | The incidence of complications during the index hospitalization and one year after surgery |
| Postoperative mortality | Inpatient hospitalization approximately 3 to 7 days, and one year after surgery | The incidence of complications during the index hospitalization and one year after surgery |
Countries
United States
Outcome results
None listed