Transcutaneous Autonomic Modulation in Thoracic Surgery (TON-POINTS)

Duke University

Status: Terminated

Conditions: Postoperative Complications; Inflammation; Atrial Fibrillation, Postoperative

Treatments: Device: Sham LLVNS; Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02783157

Pro00071148

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups

Transcutaneous low-level vagal nerve stimulation (LLVNS)

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)

Sham LLVNS

Sham Comparator group

Description:

n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.

Treatment:

Device: Sham LLVNS