Official Title
Evaluation of the Prevalence and Evolution of Autonomic Nervous System Dysfunction for the Management of SARS-COV 2 Infection in Intensive Care Unit Patients
Brief Summary

Since the spread of the COVID-19 disease, several studies have reported the presence ofneurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo oranosmia, hypopsia, the presence of headaches or neuralgia. It has also been described aninconsistent association, in the most severe patients, neurological disorders such aslabile arterial hypertension, persistent central fever, vigilance disorders as well as apoor adaptation of the cardio vascular and respiratory systems characterized byparadoxical bradycardia and the frequent absence of polypnea in response to profoundhypoxemia. These different functional signs are usually described in particular inpatients with impairment of the autonomic nervous system (ANS) in connection with otherneuropathological processes.

Detailed Description

Since the spread of the COVID-19 disease, several studies have reported the presence of
neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or
anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an
inconsistent association, in the most severe patients, neurological disorders such as
labile arterial hypertension, persistent central fever, vigilance disorders as well as a
poor adaptation of the cardio vascular and respiratory systems characterized by
paradoxical bradycardia and the frequent absence of polypnea in response to profound
hypoxemia. These different functional signs are usually described in particular in
patients with impairment of the autonomic nervous system (ANS) in connection with other
neuropathological processes.

Currently, there are few studies interesting by the neurological complications of
patients with SARS-CoV-2, the mechanisms involved in its migration to target sites and
the processes leading to damage by direct injury or related to neuro-inflammatory
processes of the CNS and in particular of the brainstem, responsible for the regulation
of the ANS.

The main objective of the study conducted is therefore to evaluate the prevalence and the
evolution of autonomic nervous system dysfunction and its impact in patients with
SARS-CoV-2 infection hospitalized in intensive care Unit (ICU) confirmed by the obtaining
a positive RT-PCR (2nd PCR carried out 3 days after the first in the event of a negative
first result). This dysfunction of Autonomic Nervous System will be diagnosed on the
basis of a multimodal assessment including spectral analysis of heart rate variability,
the tone, pupillary reactivity and tympanometry, the measurement of skin
electro-conductance, evaluation of diaphragmatic function and analysis of
electro-encephalographic characteristics.

This population of patients will be compared with a control group of subjects admitted in
ICU for the management of a suspected SARS-CoV-2 infection with a diagnosis excluded on
the basis of a set of clinical and biological and ultrasound arguments associated with
two RT-PCRs on negative respiratory samples taken 3 days apart.

Completed
Respiratory Symptoms
Autonomic Nervous System Dysfunction

Diagnostic Test: Electro-conductance measurement

Interventions are done to diagnose Autonomic Nervous system Troubles
Other Name: Tympanometry+Pupillometry

Eligibility Criteria

Inclusion Criteria:

- Patients over 18 years old, hospitalized in an intensive care unit for the
management of a suspected SARS-CoV-2 infection diagnosed by reference examination
(PCR on nasopharyngeal Sample)

- Patient affiliated or benefiting from a social security system,

- Consent obtained from the trusted person, or close person or parent, under the
conditions provided by the article L.1122-1-1 of the "CSP"

- Patient who has given consent to participate.

Exclusion Criteria:

- Bad command of French language or state incompatible with the patient's
understanding and / or enlightened adherence to the study protocol

- Adults who are the subject of legal protection or unable to express their consent

- Minors

- Lack of possible collection of signed informed consent

- History of progressive and / or degenerative neurological pathology

- Pregnant women, parturients and nursing mothers

- Therapeutic limitation decision made before inclusion of patient

- Persons deprived of their liberty by a court or administrative decision, persons
undergoing psychiatric care (article L1121-6)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Centre Hospitalier Sainte-Anne
Paris 2988507, France

DANIEL Matthieu, MD, PhD, Principal Investigator
Centre hospitalier Sainte Anne

Centre Hospitalier St Anne
NCT Number
Keywords
Covid-19
SARS-CoV 2
Respiratory symptoms
Autonomic Nervous system dysfunction
MeSH Terms
Signs and Symptoms, Respiratory
COVID-19