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

Respiratory Symptoms Clinical Trial

— COVENANT-ICU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06060795
• Other study ID #: D20-P014
• Secondary ID: IDRCB : 2020-A01
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: September 2023
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autonomic Nervous System Dysfunction
• Respiratory Symptoms
• Signs and Symptoms, Respiratory

Intervention

Diagnostic Test:
• Electro-conductance measurement
Interventions are done to diagnose Autonomic Nervous system Troubles

Locations

Country	Name	City	State
France	Centre Hospitalier Sainte-Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of an ARDS defined by the new definition of "Berlin" of acute respiratory distress syndrome (ARDS),	proposed distinguished according to the PaO2 / FiO2 ratio measured in the presence of a positive external expiratory pressure (PEPe) of at least 5 cmH2O, three levels of ARDS severity in minimal (200	Day1, Day3, Day7, Day14, Day21
Secondary	Mortality at 1 month	- Vital status at 30 days	Month 1
Secondary	Mortality at 6 months	- Vital status at 6 months	Month 6
Secondary	Sequential Organ Failure Assessment (SOFA score)	SOFA score: grade the organ function or failure rate, from 0 to 24, severity increases as the score increases.	Day1, Day3, Day7, Day14, Day21
Secondary	Total duration of mechanical ventilation, ventilatory weaning, curarization,	Total time of mechanical ventilation, weaning and use of neuromuscular blockade	Day 21