Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-04-18 @ 8:58 PM
Study NCT ID:
NCT02783157
Status:
TERMINATED
Last Update Posted:
2020-04-06
First Post:
2016-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Autonomic Modulation in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence/Burden of Postoperative Atrial Fibrillation', 'timeFrame': 'Inpatient hospitalization approximately 3 to 7 days'}], 'secondaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': 'Inpatient hospitalization approximately 3 to 7 days, and one year after surgery', 'description': 'The incidence of complications during the index hospitalization and one year after surgery'}, {'measure': 'Postoperative mortality', 'timeFrame': 'Inpatient hospitalization approximately 3 to 7 days, and one year after surgery', 'description': 'The incidence of complications during the index hospitalization and one year after surgery'}, {'measure': 'Serologic Markers of Inflammation', 'timeFrame': 'Inpatient hospitalization approximately 3 to 7 days', 'description': 'Cytokine levels, measured in pg/mL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autonomic', 'Vagal nerve stimulation', 'Postoperative atrial fibrillation'], 'conditions': ['Atrial Fibrillation, Postoperative', 'Postoperative Complications', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '25744003', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)\n\nExclusion Criteria:\n\n* Patients \\>90 or \\<40 years of age\n* Chronic atrial fibrillation\n* Prior splenectomy\n* Preoperative inotropic support\n* Hepatic or renal failure\n* Currently receiving vagal nerve stimulation therapy\n* Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine)\n* High-grade atrioventricular block (\\>2nd degree atrioventricular blockade)'}, 'identificationModule': {'nctId': 'NCT02783157', 'acronym': 'TON-POINTS', 'briefTitle': 'Transcutaneous Autonomic Modulation in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery', 'orgStudyIdInfo': {'id': 'Pro00071148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous low-level vagal nerve stimulation (LLVNS)', '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.', 'interventionNames': ['Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham LLVNS', 'description': 'n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.', 'interventionNames': ['Device: Sham LLVNS']}], 'interventions': [{'name': 'Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Transcutaneous low-level vagal nerve stimulation (LLVNS)']}, {'name': 'Sham LLVNS', 'type': 'DEVICE', 'description': 'A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.', 'armGroupLabels': ['Sham LLVNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Joseph P Mathew, MD, MHS, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}