NCT05058742

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vienna Hospital Association · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	AuriStim	Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2021-09-28
• Last updated: 2022-10-25

Locations

1 site across 1 country: Austria