The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy

Study Overview
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Brief Summary
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Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.

Official Title
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The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy

Conditions
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Inflammatory Response

Intervention / Treatment
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* Device: Vagus nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung Lobectomy or pneumonectomy Adult Open surgery Exclusion Criteria: Current infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Active Comparator: Treated<br> | Device: Vagus nerve stimulation<br>* transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations | changes of serum Interleukin (IL-6, IL-10, IL-18, IL-1) concentrations in pg/ml from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of the target interleukins at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response. | 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations | changes of serum CRP concentrations in mg/L from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of CRP at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response. | 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vagus nerve, Lung lobectomy