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

NCT ID: NCT03204968

Last Updated: 2017-07-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-06-01

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.

Detailed Description

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Conditions

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Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

Group Type NO_INTERVENTION

No interventions assigned to this group

Treated

Group Type ACTIVE_COMPARATOR

Vagus nerve stimulation

Intervention Type DEVICE

transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (DucestĀ®, Germany)

Interventions

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Vagus nerve stimulation

transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (DucestĀ®, Germany)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Lung Lobectomy or pneumonectomy
* Adult
* Open surgery

Exclusion Criteria

* Current infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otto Wagner Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Salama

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Mueller, MD, PhD

Role: STUDY_DIRECTOR

Otto Wagner Hospital

Mohamed Salama, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Otto Wagner Hospital

Locations

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Department of Thoracic Surgery, Otto-Wagner Hospital

Vienna, , Austria

Site Status

Countries

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Austria

References

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Salama M, Akan A, Mueller MR. Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve Attenuates the Acute Inflammatory Response After Lung Lobectomy. World J Surg. 2020 Sep;44(9):3167-3174. doi: 10.1007/s00268-020-05543-w.

Reference Type DERIVED
PMID: 32358638 (View on PubMed)

Other Identifiers

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Vagus Stimulation

Identifier Type: -

Identifier Source: org_study_id

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