Brainstem Dysfunction in COVID-19 Critically Ill Patients: a Prospective Observational Study (BRAINSTEM-COV)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: Brainstem Responses Assessment Sedation Score (BRASS); Diagnostic Test: Electroencephalogram with EKG lead

Study type: Interventional

Funder types: Other

Identifiers

NCT04527198

APHP200644

2020-A01559-30 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

group 1

Experimental group

Description:

Major patients, admitted in intensive care for a SARS-CoV-2 infection and requiring mechanical ventilation and deep sedation (with or without neuromuscular blockade)

Treatment:

Diagnostic Test: Electroencephalogram with EKG lead

Diagnostic Test: Brainstem Responses Assessment Sedation Score (BRASS)