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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Incidence/Burden of Postoperative Atrial Fibrillation [ Time Frame: Inpatient hospitalization approximately 3 to 7 days ]
- 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
- 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
- Serologic Markers of Inflammation [ Time Frame: Inpatient hospitalization approximately 3 to 7 days ]Cytokine levels, measured in pg/mL
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
|Contact: Nathan H Waldron, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Nathan H Waldron, MD 919-724-5217 email@example.com|
|Contact: Tiffany Bisanar, RN, BSN, CCRP 919-681-0866 firstname.lastname@example.org|
|Principal Investigator:||Joseph P Mathew, MD, MHS, MBA||Duke University|