Clinical trial NCT06060795: CoVID-19 Evaluation of Neurological and Autonomic Nervous System Troubles in Intensive Care Unit Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Symptoms
Autonomic Nervous System Dysfunction
Keywords: COVID-19
SARS-COV 2
respiratory symptoms
Autonomic Nervous system dysfunction
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The 'experimental group' population in question consisted of patients over 18 years of age at the time of inclusion, admitted to an intensive care unit or intensive care unit for the management of an established SARS-CoV-2 infection.

The 'control group' population consisted of adult patients, male or female, admitted to an intensive care unit or intensive care unit for the management of respiratory symptoms requiring continuous monitoring but whose final diagnosis was based on several clinical-biological and radiological a posteriori, is not related to SARS-CoV-2 infection and has two negative RT-PCRs for SARS-CoV-2 performed three days apart (1st PCR performed on admission to the ward and re-sampling in case of first negative PCR).

Brief summary: 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.

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.

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)

Primary outcomes:
measure: Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated
timeFrame: Day1, Day3, Day7, Day14, Day21
Secondary outcomes:
measure: Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS),
timeFrame: Day1, Day3, Day7, Day14, Day21
measure: Mortality at 1 month
timeFrame: Month 1
measure: Mortality at 6 months
timeFrame: Month 6
measure: Sequential Organ Failure Assessment (SOFA score)
timeFrame: Day1, Day3, Day7, Day14, Day21
measure: Total duration of mechanical ventilation, ventilatory weaning, curarization,
timeFrame: Day 21
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
Study officials:
affiliation: Centre hospitalier Sainte Anne
name: DANIEL Matthieu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: