Clinical trial NCT05058742: Non-invasive Nervus Vagus Stimulation in Patients With COVID-19 and ARDS
Official title: Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
ARDS
Cytokine Storm
Keywords: Nervus vagus stimulation
COVID-19
ARDS
hyperinflammation
cytokine storm
Lead sponsor: Vienna Hospital Association
Sponsor class: OTHER_GOV
First posted: 2021-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
timeFrame: 3 months after admission to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Favoriten
Study officials:
affiliation: Klinik Favoriten
name: Alexander Zoufaly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vienna University of Technology
name: Eugenijus Kaniusas, Prof. Dr.
role: STUDY_CHAIR
References: