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Transcutaneous Autonomic Modulation in Thoracic Surgery (TON-POINTS)

Primary Purpose

Atrial Fibrillation, Postoperative, Postoperative Complications, Inflammation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
Sham LLVNS
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation, Postoperative focused on measuring Autonomic, Vagal nerve stimulation, Postoperative atrial fibrillation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcutaneous low-level vagal nerve stimulation (LLVNS)

Sham LLVNS

Arm 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.

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

Outcomes

Primary Outcome Measures

Incidence/Burden of Postoperative Atrial Fibrillation

Secondary Outcome Measures

Postoperative morbidity
The incidence of complications during the index hospitalization and one year after surgery
Postoperative mortality
The incidence of complications during the index hospitalization and one year after surgery
Serologic Markers of Inflammation
Cytokine levels, measured in pg/mL

Full Information

First Posted
April 13, 2016
Last Updated
April 3, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02783157
Brief Title
Transcutaneous Autonomic Modulation in Thoracic Surgery
Acronym
TON-POINTS
Official Title
Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Postoperative, Postoperative Complications, Inflammation
Keywords
Autonomic, Vagal nerve stimulation, Postoperative atrial fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous low-level vagal nerve stimulation (LLVNS)
Arm Type
Experimental
Arm 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.
Arm Title
Sham LLVNS
Arm Type
Sham Comparator
Arm Description
n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham LLVNS
Intervention Description
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.
Primary Outcome Measure Information:
Title
Incidence/Burden of Postoperative Atrial Fibrillation
Time Frame
Inpatient hospitalization approximately 3 to 7 days
Secondary Outcome Measure Information:
Title
Postoperative morbidity
Description
The incidence of complications during the index hospitalization and one year after surgery
Time Frame
Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Title
Postoperative mortality
Description
The incidence of complications during the index hospitalization and one year after surgery
Time Frame
Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Title
Serologic Markers of Inflammation
Description
Cytokine levels, measured in pg/mL
Time Frame
Inpatient hospitalization approximately 3 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Mathew, MD, MHS, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25744003
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.
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Transcutaneous Autonomic Modulation in Thoracic Surgery

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