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

NCT06060795 | Completed

• 2 other identifiers: D20-P014IDRCB : 2020-A01003-36
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Symptoms; Autonomic Nervous System Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence and ANS dysfunction defined by the presence of the following criteria, isolated or associated

  * Criterion 1: A significant change in the LF / HF ratio and AUCHR compared to baseline and control group * Criterion 2: A significant change in the measurement of average skin conductances on the hands and feet in COVID-19 patients compared to baseline and control group * Criterion 3: A significant change in basic tone and pupillary reactivity to light stimuli and pain in COVID-19 patients compared to baseline measures and control group * Criterion 4: A significant change in the tympanic reflex observed in COVID-19 patients compared to baseline and control group, * Criterion 5: Presence of significant changes in EEG pattern and evolution between COVID-19 patients and control group

  Day1, Day3, Day7, Day14, Day21

Secondary Outcomes (5)

• Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS),

  Day1, Day3, Day7, Day14, Day21

• Mortality at 1 month

  Month 1

• Mortality at 6 months

  Month 6

• Sequential Organ Failure Assessment (SOFA score)

  Day1, Day3, Day7, Day14, Day21

• Total duration of mechanical ventilation, ventilatory weaning, curarization,

  Day 21

Study Arms (2)

Experimental Group

Patient infected by COVID19

Diagnostic Test: Electro-conductance measurement

Control group

Patient non infected by COVID19

Diagnostic Test: Electro-conductance measurement

Interventions

Electro-conductance measurement DIAGNOSTIC_TEST

Interventions are done to diagnose Autonomic Nervous system Troubles

Also known as: Tympanometry+Pupillometry

Control group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, France

Location

MeSH Terms

Conditions

Signs and Symptoms, Respiratory; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• DANIEL Matthieu, MD, PhD

  Centre hospitalier Sainte Anne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2023
• Study Start: April 6, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)