Official Title
Brainstem Dysfunction in Ventilated and Deeply Sedated COVID-19 Critically Ill Patients: a Prospective Observational Study
Brief Summary

The purpose of this study is to determine the prevalence of brainstem dysfunction in critically ill ventilated and deeply sedated patients hospitalized in the Intensive Care Unit (ICU) for a SARS-CoV-s2 infection.

Detailed Description

The recent development of the pandemic due to the SARS-CoV-2 virus has showed that a
substantial proportion of patients developed a severe condition requiring critical care,
notably because of acute respiratory distress syndrome requiring mechanical ventilation and
deep sedation. Outside of this coronavirus infection, this situation is classically
associated with a high prevalence of brainstem dysfunction, even in the absence of brain
injury. This dysfunction, either structural or functional, can be detected using appropriate
clinical tools such as the BRASS score and/or using the quantitative analysis of EKG and EEG.
Crucially, brainstem dysfunction is associated not only with ICU complications such as
delirium, but also with a poorer survival.

Moreover, some reports of encephalitis cases and the presence of anosmia/agueusia raised the
question of whether the virus could directly invade the central nervous system.

For these two reasons, it is reasonable to assume that brainstem dysfunction is particularly
prevalent in critically ill patients infected with SARS-CoV-2 and that this dysfunction could
be one of the major determinant of patients outcome.

Completed
COVID-19

Diagnostic Test: Brainstem Responses Assessment Sedation Score (BRASS)

It consists of a standardized evaluation of brainstem reflexes with a score of 1 attributed for absence of pupillary light reflex, cough reflex and the combined absence of grimace and oculocephalic reflex, a score of 2 for absent corneal reflex and a score of 3 for absent grimace in the presence of oculocephalic The resulting sum ranges from 0 to 7.
It will be performed at two times points: a first time under sedation and a second time 3 to 5 days after sedation weaning.

Diagnostic Test: Electroencephalogram with EKG lead

A 20 minutes clinical (12 electrodes) EEG with an EKG lead will be performed a first time under sedation and a second time 3 to 5 days after sedation weaning.
These EEG recordings will allow to measure the sympathic-parasympathetic ratio using spectral analysis of the EKG and also to measure quantitative markers of brain EEG activity (spectral power and connectivity in delta, theta, alpha, beta and gamma band; complexity).
Other Name: EEG

Eligibility Criteria

Inclusion Criteria:

- ICU hospitalization

- Invasive mechanical ventilation

- Deep sedation (RASS<-3) >12 hours

- Positive SARS-COV-2 PCR

Exclusion Criteria:

- History of neurologic disease (stroke, degenerative disease)

- Pregnant women

- Moribund patients

- Minor patient

- Major patient under guardianship or curatorship

- Prior inclusion in the study

- Patient not affiliated to a social security scheme

- Limitations and cessation of active therapies

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Hôpital Cochin
Paris, France

HEGP
Paris, France

Bertrand HERMANN, MD, PhD, Principal Investigator
Assistance Publique - Hôpitaux de Paris

Assistance Publique - Hôpitaux de Paris
NCT Number
Keywords
Brainstem dysfunction
DELIRIUM
awareness
Arousal
Dysautonomia
Autonomic system
SARS-CoV-2
Covid-19
Sedation
Mechanical Ventilation
EEG
EKG
MeSH Terms
COVID-19