Transcutaneous Autonomic Modulation in Thoracic Surgery

Inflammation Clinical Trial

— TON-POINTS  

Official title:

Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02783157
• Other study ID #: Pro00071148
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: February 21, 2020

Study information

• Verified date: April 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Postoperative
• Inflammation
• Postoperative Complications

Intervention

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.
• Sham LLVNS
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence/Burden of Postoperative Atrial Fibrillation		Inpatient hospitalization approximately 3 to 7 days
Secondary	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
Secondary	Postoperative mortality	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
Secondary	Serologic Markers of Inflammation	Cytokine levels, measured in pg/mL	Inpatient hospitalization approximately 3 to 7 days