Inflammatory Response
Conditions
Keywords
vagus nerve, Lung lobectomy
Brief summary
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.
Interventions
DEVICEVagus nerve stimulation
transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)
Sponsors
Otto Wagner Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lung Lobectomy or pneumonectomy * Adult * Open surgery
Exclusion criteria
* Current infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations | 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations | 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day | 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. |
Countries
Austria
Outcome results
None listed