TON-POINTS: Transcutaneous Autonomic Modulation in Thoracic Surgery

Sponsor

Duke University (Other)

Overall Status

Terminated

CT.gov ID

NCT02783157

Collaborator

(none)

Enrollment

Location

Arms

45.7

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation, Postoperative Postoperative Complications Inflammation	Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) Device: Sham LLVNS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Feb 21, 2020

Actual Study Completion Date :

Feb 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Sham Comparator: Sham LLVNS n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.	Device: Sham LLVNS A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Sham Comparator: Sham LLVNS

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

Device: Sham LLVNS

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

Outcome Measures

Primary Outcome Measures

Incidence/Burden of Postoperative Atrial Fibrillation [Inpatient hospitalization approximately 3 to 7 days]

Secondary Outcome Measures

Postoperative morbidity [Inpatient hospitalization approximately 3 to 7 days, and one year after surgery]
The incidence of complications during the index hospitalization and one year after surgery
Postoperative mortality [Inpatient hospitalization approximately 3 to 7 days, and one year after surgery]
The incidence of complications during the index hospitalization and one year after surgery
Serologic Markers of Inflammation [Inpatient hospitalization approximately 3 to 7 days]
Cytokine levels, measured in pg/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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)