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

NCT05058742 | Unknown

• 1 other identifier: VNS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; ARDS; Cytokine Storm

Keywords

Nervus vagus stimulation; COVID-19; ARDS; hyperinflammation; cytokine storm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nervus vagus stimulation

EXPERIMENTAL

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

Control

NO INTERVENTION

There is no Nervus vagus stimulation.

Interventions

AuriStim DEVICE

Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve

Nervus vagus stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positive SARS-CoV-2 RT-PCR
• Acute respiratory failure requiring non-invasive respiratory support (NIV or high flow Oxygen)
• PaO2/FiO2 \<200

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Hospital Association: lead

Study Sites (1)

Klinik Favoriten

Vienna, 1100, Austria

RECRUITING

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Alexander Zoufaly, MD

  Klinik Favoriten

  PRINCIPAL INVESTIGATOR

• Eugenijus Kaniusas, Prof. Dr.

  Vienna University of Technology

  STUDY CHAIR

Central Study Contacts

Reinhard Kitzberger, MD

CONTACT

+431601910; reinhard.kitzberger@gesundheitsverbund.at

Tamara Seitz, MD

CONTACT

+4316019172412; tamara.seitz@gesundheitsverbund.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: September 28, 2021
• Study Start: July 15, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)