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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; ARDS; Cytokine Storm
• Intervention / Treatment: Device: AuriStim

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reinhard Kitzberger, MD; Phone Number: +431601910; Email: reinhard.kitzberger@gesundheitsverbund.at
• Study Contact Backup: Name: Tamara Seitz, MD; Phone Number: +4316019172412; Email: tamara.seitz@gesundheitsverbund.at

Study Locations

• Austria
  • Vienna, Austria, 1100
    • Recruiting
    • Klinik Favoriten
    • Contact: Reinhard Kitzberger, MD; Phone Number: +4301601910; Email: reinhard.kitzberger@gesundheitsverbund.at
    • Contact: Tamara Seitz, MD; Phone Number: +43016019172412; Email: tamara.seitz@gesundheitsverbund.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nervus vagus stimulation; 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; Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve
No Intervention: Control; There is no Nervus vagus stimulation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vienna Hospital Association
• Investigators: Principal Investigator: Alexander Zoufaly, MD, Klinik Favoriten; Study Chair: Eugenijus Kaniusas, Prof. Dr., Vienna University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; cytokine storm; Nervus vagus stimulation; hyperinflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Shock; COVID-19; Cytokine Release Syndrome
• Other Study ID Numbers: VNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No