Clinical trial NCT02783157: Transcutaneous Autonomic Modulation in Thoracic Surgery
Official title: Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation, Postoperative
Postoperative Complications
Inflammation
Keywords: Autonomic
Vagal nerve stimulation
Postoperative atrial fibrillation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence/Burden of Postoperative Atrial Fibrillation
timeFrame: Inpatient hospitalization approximately 3 to 7 days
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
measure: Postoperative mortality
timeFrame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
measure: Serologic Markers of Inflammation
timeFrame: Inpatient hospitalization approximately 3 to 7 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph P Mathew, MD, MHS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.