| Trial registration number
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NCT05058742 |
Full text link
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05058742
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First author
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Reinhard Kitzberger, MD
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Contact
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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reinhard.kitzberger@gesundheitsverbund.at
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Registration date
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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2021-09-28
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Recruitment status
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- positive sars-cov-2 rt-pcr
- acute respiratory failure requiring non-invasive respiratory support (niv or high flow
oxygen)
- pao2/fio2 <200
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Exclusion criteria
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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- 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
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Number of arms
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Vienna Hospital Association
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Inclusion age min
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Austria
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Type of patients
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Nervus vagus stimulation decreases the rate of complications (e.g. need of mechanical ventilation, hospital stay, mortality)
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Notes
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 903, "treatment_name": "Non-invasive vagus nerve stimulator", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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