Brainstem Dysfunction in COVID-19 Critically Ill Patients: a Prospective Observational Study

NCT04527198 | Completed

• 2 other identifiers: APHP2006442020-A01559-30
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

Brainstem dysfunction; Delirium; Awareness; Arousal; Dysautonomia; Autonomic system; SARS-COV-2; COVID-19; sedation; mechanical ventilation; EEG; EKG

Outcome Measures

Primary Outcomes (1)

• Brainstem dysfunction prevalence

  Clinical cranial nerves anomalies using validated scale (BRASS score- ranges from 0 to 7 - ) in deeply sedated patient (RASS \<-3)

  At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation

Secondary Outcomes (17)

• Brainstem dysfunction prevalence after sedation weaning

  Day 4 to day 7 after sedation weaning

• Link between brainstem dysfunction and clinical dysautonomia

  At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessationn

• Link between brainstem dysfunction and clinical dysautonomia after sedation weaning

  4 to 7 days after sedation weaning

• Characterization of brainstem dysfunction in COVID-19 patients: EEG power

  At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation

• Characterization of brainstem dysfunction in COVID-19 patients: EEG power after sedation weaning

  Day 4 to day 7 after sedation weaning.

Study Arms (1)

group 1

EXPERIMENTAL

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

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

Interventions

Brainstem Responses Assessment Sedation Score (BRASS) DIAGNOSTIC_TEST

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.

group 1

Electroencephalogram with EKG lead DIAGNOSTIC_TEST

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).

Also known as: EEG

group 1

Eligibility Criteria

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

You may qualify if:

• ICU hospitalization
• Invasive mechanical ventilation
• Deep sedation (RASS\<-3) \>12 hours
• Positive SARS-COV-2 PCR

You may not qualify if:

• History of neurologic disease (stroke, degenerative disease)
• Pregnant women
• Moribund patients
• Minor patient
• Major patient under guardianship or curatorship
• Patient not affiliated to a social security scheme
• Limitations and cessation of active therapies

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Cochin

Paris, 75014, France

Location

HEGP

Paris, 75015, France

Location

Related Publications (2)

• Rohaut B, Porcher R, Hissem T, Heming N, Chillet P, Djedaini K, Moneger G, Kandelman S, Allary J, Cariou A, Sonneville R, Polito A, Antona M, Azabou E, Annane D, Siami S, Chretien F, Mantz J, Sharshar T; Groupe d'Exploration Neurologique en Reanimation (GENER). Brainstem response patterns in deeply-sedated critically-ill patients predict 28-day mortality. PLoS One. 2017 Apr 25;12(4):e0176012. doi: 10.1371/journal.pone.0176012. eCollection 2017.

  PMID: 28441453 BACKGROUND

• Benghanem S, Cariou A, Diehl JL, Marchi A, Charpentier J, Augy JL, Hauw-Berlemont C, Gavaret M, Pene F, Mira JP, Sharshar T, Hermann B. Early Clinical and Electrophysiological Brain Dysfunction Is Associated With ICU Outcomes in COVID-19 Critically Ill Patients With Acute Respiratory Distress Syndrome: A Prospective Bicentric Observational Study. Crit Care Med. 2022 Jul 1;50(7):1103-1115. doi: 10.1097/CCM.0000000000005491. Epub 2022 Feb 9.

  PMID: 35135966 RESULT

MeSH Terms

Conditions

COVID-19; Delirium; Autonomic Nervous System Diseases

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Bertrand HERMANN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: August 26, 2020
• Study Start: September 14, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)