Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study
NCT ID: NCT04374045
Last Updated: 2021-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2020-04-30
2020-06-18
Brief Summary
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At the same time, there is now strong experimental evidence that SARS-CoV-2 can cross the blood-brain barrier, probably via the olfactory nerves, and reach the brain stem, which is located in close proximity.
Damage to the brainstem nuclei could explain the suspected dysautonomic episodes, but also the severity of respiratory distress in infected patients, and the difficulty of ventilatory withdrawal encountered in resuscitation, potentially through damage to the ventilation control and regulation centers located in the brainstem.
The objective of this study is to record the long term variability in heart rate, reflecting autonomic balance, of patients screened positive for SARS-CoV-2 throughout their stay in conventional care units at the Saint-Etienne University Hospital, in order to see whether there is an autonomic imbalance at screening, whether the worsening of the autonomic imbalance precedes the worsening of the clinical condition, and how quickly the expected correction of the autonomic imbalance follows or precedes that of the disease.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with SARS-CoV-2
patients having a continuous recording of the heart rhythm during their hospitalization
ECG-Holter
Patient will have a ECG-Holter recording during all their hospitalization.
Interventions
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ECG-Holter
Patient will have a ECG-Holter recording during all their hospitalization.
Eligibility Criteria
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Inclusion Criteria
* with clinical signs of SARS-CoV-2
* understanding and speaking French fluently to understand the explanations and participate in the study
* who have given their oral consent to participate in the study
* affiliated or entitled to a social security scheme.
Exclusion Criteria
* with atrial fibrillation on the ECG trace taken at the time of their entry.
* refusing to participate in the study
* intubated prior to inclusion in the study
* that are within the exclusion period of another research protocol
* with a history of head injury, neurological pathology with a brain impact, or serious unstable somatic disease
* patient under guardianship.
* pregnancy woman
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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David CHARIER, MD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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CHU Hopital nord
Saint-Etienne, , France
Countries
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References
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Daniel M, Charier D, Pereira B, Pachcinski M, Sharshar T, Molliex S. Prognosis value of pupillometry in COVID-19 patients admitted in intensive care unit. Auton Neurosci. 2023 Mar;245:103057. doi: 10.1016/j.autneu.2022.103057. Epub 2022 Dec 17.
Other Identifiers
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2020-A01082-37
Identifier Type: OTHER
Identifier Source: secondary_id
20CH095
Identifier Type: -
Identifier Source: org_study_id
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