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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058742
• Other study ID #: VNS
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2022
• Source: Vienna Hospital Association
• Contact: Reinhard Kitzberger, MD
• Phone: +431601910
• Email: reinhard.kitzberger[@]gesundheitsverbund.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Cytokine Release Syndrome
• Cytokine Storm

Intervention

Device:
• AuriStim
Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve

Locations

Country	Name	City	State
Austria	Klinik Favoriten	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Hospital Association

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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