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

Vienna Hospital Association

Status: Enrolling

Conditions: COVID-19; Cytokine Storm; ARDS

Treatments: Device: AuriStim

Study type: Interventional

Funder types: Other

Identifiers

NCT05058742

VNS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nervus vagus stimulation

Experimental group

Description:

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.

Treatment:

Device: AuriStim

Control

No Intervention group

Description:

There is no Nervus vagus stimulation.