Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS

Study Overview
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Brief Summary
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Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients.

Detailed Description
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Introduction: Critical ill COVID-19 patients often develop respiratory, hemodynamic and neuropsychiatric complications. An imbalance of sympatho-parasympathetic nervous system is discussed as one of the reasons. The nervus vagus is essential for controlling the sympatho-parasympathetic nervous system and the inflammatory processes. A method to stimulate the nervus vagus, is the non-invasive Nervus Vagus Stimulation with AuriStim. Aims: Aim of this study is to evaluate whether Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) in critical ill patients. Methods: All patients admitted to ICU at Klinik Favoriten with COVID-19 and moderate to severe ARDS are asked to partcipate. After written consent, a randomisation in Treatment-group (Vagal Nervus Stimulation 4 times a day for each 3 hours until transfer to nomal ward or death) or Non-Treatment-Group is done. In case of stimulation, side effects or intolerance are documented. After discharge or death of the patient, outcomeparameters are evaluated (need of mechanical ventilation, hospital stay, mortality, etc.) and compared between patients of Treatment-Group and Non-Treatment-Group.

Official Title
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Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications

Conditions
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COVID-19, ARDS, Cytokine Storm

Intervention / Treatment
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* Device: AuriStim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive SARS-CoV-2 RT-PCR Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen) PaO2/FiO2 <200 Exclusion Criteria: Age <18 years Pregnancy (to be excluded using Serum betaHCG in women of childbearing age) Signs of infection, eczema or Psoriasis at the application site Active malignancy Implanted cardiac Pacemaker, deficrillator or other active implanted electrical devices Patient unable to consent Heart rate <60/min Known vagal hypersensitivity History of hemophilia

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nervus vagus stimulation<br>Non-invasive Nervus vagus stimulation called AuriStim Intermittent stimluation cycle of three hours of activity and three hours of rest, equating to four cycles of three hours of Stimulation in 24 hours) is performed. The stimulation is performed until the patient's condition is better and he or she isdischarged from OCU or transferred to normal ward or dies. | Device: AuriStim<br>* Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve<br>|
| No Intervention: Control<br>There is no Nervus vagus stimulation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality) | retrospective analysis after discharge or death or participant | 3 months after admission to ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervus vagus stimulation, COVID-19, ARDS, hyperinflammation, cytokine storm