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

Sponsor
Vienna Hospital Association (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058742
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
7.5
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AuriStim
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Noninvasive Vagal Nerve Stimulation in Patients With COVID-19 and ARDS for the Reduction of Respiratory, Hemodynamic and Neuropsychiatric Complications
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Nervus vagus stimulation

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.

Device: AuriStim
Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve

No Intervention: Control

There is no Nervus vagus stimulation.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Klinik FavoritenViennaAustria1100

Sponsors and Collaborators

  • Vienna Hospital Association

Investigators

  • Principal Investigator: Alexander Zoufaly, MD, Klinik Favoriten

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vienna Hospital Association
ClinicalTrials.gov Identifier:
NCT05058742
Other Study ID Numbers:
  • VNS
First Posted:
Sep 28, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Vienna Hospital Association
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021