Transcutaneous Autonomic Modulation in Thoracic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation, Postoperative Postoperative Complications Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)

Intervention Type DEVICE

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 LLVNS

n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.

Group Type SHAM_COMPARATOR

Sham LLVNS

Intervention Type DEVICE

A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.

Interventions

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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.

Intervention Type DEVICE

Sham LLVNS

A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No