Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous low-level vagal nerve stimulation (LLVNS) | Experimental | n=100 patients will be randomized to transcutaneous low-level vagal nerve stimulation (LLVNS), via a clip applied to the ear. Stimulation will be delivered throughout the procedure. |
|
| Sham LLVNS | Sham Comparator | n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence/Burden of Postoperative Atrial Fibrillation | Inpatient hospitalization approximately 3 to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity | The incidence of complications during the index hospitalization and one year after surgery | Inpatient hospitalization approximately 3 to 7 days, and one year after surgery |
| Postoperative mortality |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph P Mathew, MD, MHS, MBA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25744003 | Background | Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D011183 | Postoperative Complications |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham LLVNS | Device | A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure. |
|
The incidence of complications during the index hospitalization and one year after surgery
| Inpatient hospitalization approximately 3 to 7 days, and one year after surgery |
| Serologic Markers of Inflammation | Cytokine levels, measured in pg/mL | Inpatient hospitalization approximately 3 to 7 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |