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NCT02783157 · ClinicalTrials.gov registry record · NA
Transcutaneous Autonomic Modulation in Thoracic Surgery
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT02783157 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 2 participants.
The verdict
NCT02783157, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
- DEVICE Sham LLVNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-05 |
| Est. Completion | 2020-02-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02783157
The ClinicalTrials.gov registry entry for NCT02783157 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) is the first listed.
NCT02783157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02783157 about?
NCT02783157 is a clinical study titled "Transcutaneous Autonomic Modulation in Thoracic Surgery". 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 ...
What is the current status of trial NCT02783157?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2016-05. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02783157?
The interventions under investigation include: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) (DEVICE), Sham LLVNS (DEVICE).
Who is sponsoring clinical trial NCT02783157?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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