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Transcutaneous Autonomic Modulation in Thoracic Surgery (TON-POINTS)

Duke University logo

Duke University

Status

Terminated

Conditions

Postoperative Complications
Inflammation
Atrial Fibrillation, Postoperative

Treatments

Device: Sham LLVNS
Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)

Study type

Interventional

Funder types

Other

Identifiers

NCT02783157
Pro00071148

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2 participants in 2 patient groups

Transcutaneous low-level vagal nerve stimulation (LLVNS)
Experimental group
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.
Treatment:
Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
Sham LLVNS
Sham Comparator group
Description:
n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.
Treatment:
Device: Sham LLVNS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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