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

NCT ID: NCT05058742

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-11-30

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.

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.

Conditions

COVID-19; ARDS; Cytokine Storm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AuriStim

Intervention Type: DEVICE

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

Control

There is no Nervus vagus stimulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AuriStim

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Hospital Association

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Zoufaly, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik Favoriten

Eugenijus Kaniusas, Prof. Dr.

Role: STUDY_CHAIR

Vienna University of Technology

Locations

Klinik Favoriten

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Reinhard Kitzberger, MD

Role: CONTACT

reinhard.kitzberger@gesundheitsverbund.at

+431601910

Tamara Seitz, MD

Role: CONTACT

tamara.seitz@gesundheitsverbund.at

+4316019172412

Facility Contacts

Reinhard Kitzberger, MD

Role: primary

reinhard.kitzberger@gesundheitsverbund.at

+4301601910

Tamara Seitz, MD

Role: backup

tamara.seitz@gesundheitsverbund.at

+43016019172412

Other Identifiers

VNS

Identifier Type: -

Identifier Source: org_study_id