Testing for Dysautonomia in Patients Hospitalized for SARS-CoV-2 Infection (COVID-19) : COVIDANS Study

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: SARS-CoV 2

Treatments: Other: ECG-Holter

Study type: Observational

Funder types: Other

Identifiers

NCT04374045

20CH095

2020-A01082-37 (Other Identifier)

Details and patient eligibility

About

A number of clinical features suggest the possibility of dysautonomia in patients infected with SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2).

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.

Full description

In this study, patients will have a continuous recording of their heart rhythm via a holter-ECG throughout their hospitalization.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• major
• 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 a history of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomic stage
• 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

Trial design

50 participants in 1 patient group

Patients with SARS-CoV-2

Description:

patients having a continuous recording of the heart rhythm during their hospitalization

Treatment:

Other: ECG-Holter