Non-invasive Nervus Vagus Stimulation in Patients With CO... | NCT05058742

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

NCT05058742

Sponsor

Vienna Hospital Association

Status

Unknown status

Last Update Posted

Oct 25, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

COVID-19
ARDS
Cytokine Storm

Interventions

AuriStim

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2021Actual

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Nov 30, 2022Estimated

First Submitted Date

Sep 25, 2021

First Submission Date that Met QC Criteria

Sep 25, 2021

First Posted Date

Sep 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2022

Last Update Posted Date

Oct 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nervus vagus stimulation	Experimental	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
Control	No Intervention	There is no Nervus vagus stimulation.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AuriStim	Device	Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve	Nervus vagus stimulation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reinhard Kitzberger, MD	Contact	+431601910		reinhard.kitzberger@gesundheitsverbund.at
Tamara Seitz, MD	Contact	+4316019172412		tamara.seitz@gesundheitsverbund.at

Overall Officials

Name	Affiliation	Role
Alexander Zoufaly, MD	Klinik Favoriten	Principal Investigator
Eugenijus Kaniusas, Prof. Dr.	Vienna University of Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Favoriten	Recruiting	Vienna		1100	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D000080424	Cytokine Release Syndrome

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided