Transcutaneous Autonomic Modulation in Thoracic Surgery
Stopped early · Not applicable · Has a placebo group
Conditions studied: Atrial Fibrillation, Postoperative, Postoperative Complications, Inflammation
In brief
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.
Key facts
- Study ID
- NCT02783157
- Run by
- Duke University
- People needed
- 2
- Starts
- 2016-05-01
- Expected to finish
- 2020-02-21
- Last updated by the study team
- 2020-04-06
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)
You may not qualify if…
- 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)
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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