NCT02783157

Transcutaneous Autonomic Modulation in Thoracic Surgery

Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation, Postoperative
• Postoperative Complications
• Inflammation

Interventions

Type	Name	Description
DEVICE	Transcutaneous 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.
DEVICE	Sham LLVNS	A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-02-21
• Completion: 2020-02-21
• First posted: 2016-05-26
• Last updated: 2020-04-06

Locations

1 site across 1 country: United States