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Transcutaneous Autonomic Modulation in Thoracic Surgery (TON-POINTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783157
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation, Postoperative Postoperative Complications Inflammation Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) Device: Sham LLVNS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcutaneous low-level vagal nerve stimulation (LLVNS)
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)
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 Comparator: Sham LLVNS
n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.
Device: Sham LLVNS
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.




Primary Outcome Measures :
  1. Incidence/Burden of Postoperative Atrial Fibrillation [ Time Frame: Inpatient hospitalization approximately 3 to 7 days ]

Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery ]
    The incidence of complications during the index hospitalization and one year after surgery

  2. Postoperative mortality [ Time Frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery ]
    The incidence of complications during the index hospitalization and one year after surgery

  3. Serologic Markers of Inflammation [ Time Frame: Inpatient hospitalization approximately 3 to 7 days ]
    Cytokine levels, measured in pg/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783157


Contacts
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Contact: Nathan H Waldron, MD 919-724-5217 nathan.waldron@dm.duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Nathan H Waldron, MD    919-724-5217    nathan.waldron@dm.duke.edu   
Contact: Tiffany Bisanar, RN, BSN, CCRP    919-681-0866    tiffany.bisanar@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Joseph P Mathew, MD, MHS, MBA Duke University

Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02783157    
Other Study ID Numbers: Pro00071148
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Autonomic
Vagal nerve stimulation
Postoperative atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Inflammation
Postoperative Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes