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

Not Applicable

Recruiting

• Conditions: ARDS; COVID-19; Cytokine Storm
• Interventions: Device: AuriStim

• Registration Number: NCT05058742
• Lead Sponsor: Vienna Hospital Association

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.

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-09-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nervus vagus stimulation	AuriStim	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.

Primary Outcome Measures

Name	Time	Method
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)	3 months after admission to ICU	retrospective analysis after discharge or death or participant

Trial Locations

Locations (1)

Klinik Favoriten; 🇦🇹 Vienna, Austria