Respiratory Symptoms Clinical Trial
— COVENANT-ICUOfficial 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
Verified date | September 2023 |
Source | Centre Hospitalier St Anne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Sainte-Anne | Paris |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier St Anne |
France,
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 |
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