Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
Time Frame: 3 months after admission to ICU
retrospective analysis after discharge or death or participant
Secondary Outcomes
No secondary outcomes reported