NCT02783157

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

April 13, 2016

Last Update Submit

April 3, 2020

Conditions

Atrial Fibrillation, PostoperativePostoperative ComplicationsInflammation

Keywords

AutonomicVagal nerve stimulationPostoperative atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence/Burden of Postoperative Atrial Fibrillation

    Inpatient hospitalization approximately 3 to 7 days

Secondary Outcomes (3)

  • Postoperative morbidity

    Inpatient hospitalization approximately 3 to 7 days, and one year after surgery

  • Postoperative mortality

    Inpatient hospitalization approximately 3 to 7 days, and one year after surgery

  • Serologic Markers of Inflammation

    Inpatient hospitalization approximately 3 to 7 days

Study Arms (2)

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.

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

Sham LLVNS

SHAM COMPARATOR

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

Device: Sham LLVNS

Interventions

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.

Transcutaneous low-level vagal nerve stimulation (LLVNS)
Sham LLVNSDEVICE

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

Sham LLVNS

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

    PMID: 25744003BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationPostoperative ComplicationsInflammation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph P Mathew, MD, MHS, MBA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

May 26, 2016

Study Start

May 1, 2016

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

US(1)