CoVID-19 Evaluation of Neurological and Autonomic Nervous System Troubles in Intensive Care Unit Patients

NCT ID: NCT06060795

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2021-01-13

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.

Conditions

Respiratory Symptoms; Autonomic Nervous System Dysfunction

Keywords

COVID-19; SARS-COV 2; respiratory symptoms; Autonomic Nervous system dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental Group

Patient infected by COVID19

Electro-conductance measurement

Intervention Type: DIAGNOSTIC_TEST

Interventions are done to diagnose Autonomic Nervous system Troubles

Control group

Patient non infected by COVID19

Electro-conductance measurement

Intervention Type: DIAGNOSTIC_TEST

Interventions are done to diagnose Autonomic Nervous system Troubles

Interventions

Electro-conductance measurement

Interventions are done to diagnose Autonomic Nervous system Troubles

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DANIEL Matthieu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier Sainte Anne

Locations

Centre Hospitalier Sainte-Anne

Paris, , France

Countries

France

Other Identifiers

IDRCB : 2020-A01003-36

Identifier Type: OTHER

Identifier Source: secondary_id

D20-P014

Identifier Type: -

Identifier Source: org_study_id