Transcutaneous Autonomic Modulation in Thoracic Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 8/2/2018 |
| Start Date: | May 2016 |
| End Date: | July 2020 |
| Contact: | Nathan H Waldron, MD |
| Email: | nathan.waldron@dm.duke.edu |
| Phone: | 919-724-5217 |
Transcutaneous Autonomic Modulation to Prevent Organ Injury After 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 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.
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.
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)
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