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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
52
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.
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).
Hôpital Cochin
Paris, France
HEGP
Paris, France
Brainstem dysfunction prevalence
Clinical cranial nerves anomalies using validated scale (BRASS score- ranges from 0 to 7 - ) in deeply sedated patient (RASS \<-3)
Time frame: At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation
Brainstem dysfunction prevalence after sedation weaning
Clinical cranial nerves anomalies using validated scale (BRASS score)
Time frame: Day 4 to day 7 after sedation weaning
Link between brainstem dysfunction and clinical dysautonomia
Analysis of the sympathico-parasympathetic ratio (using spectral analysis of the EKG signal) according to the presence or absence of brainstem dysfunction and its severity
Time frame: 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
Analysis of the sympathico-parasympathetic ratio (using spectral analysis of the EKG signal) according to the presence or absence of brainstem dysfunction and its severity
Time frame: 4 to 7 days after sedation weaning
Characterization of brainstem dysfunction in COVID-19 patients: EEG power
EEG power in delta, theta, alpha, beta and gamma frequency bands according to the presence or absence of brainstem dysfunction and its severity
Time frame: 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
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EEG power in delta, theta, alpha, beta and gamma frequency bands according to the presence or absence of brainstem dysfunction and its severity
Time frame: Day 4 to day 7 after sedation weaning.
Characterization of brainstem dysfunction in COVID-19 patients: EEG functional connectivity
EEG functional connectivity using weighted Symbolic Mutual Information and weighted Phase Lag Index according to the presence or absence of brainstem dysfunction and its severity
Time frame: At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation
Characterization of brainstem dysfunction in COVID-19 patients: EEG functional connectivity, after sedation weaning
EEG functional connectivity using weighted Symbolic Mutual Information and weighted Phase Lag Index according to the presence or absence of brainstem dysfunction and its severity
Time frame: Day 4 to day 7 after sedation weaning.
Characterization of brainstem dysfunction in COVID-19 patients: EEG complexity
EEG complexity using Kolmogorov complexity and permutation entropy according to the presence or absence of brainstem dysfunction and its severity
Time frame: At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation
Characterization of brainstem dysfunction in COVID-19 patients: EEG complexity after sedation weaning
EEG complexity using Kolmogorov complexity and permutation entropy according to the presence or absence of brainstem dysfunction and its severity
Time frame: Day 4 to day 7 after sedation weaning.
Characterization of brainstem dysfunction in COVID-19 patients: multivariate classification
Multivariate classification of the presence or absence of brainstem dysfunction using support vector machine and extra-trees algorithm based on the EEG derived quantitative features presented above
Time frame: At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation
Characterization of brainstem dysfunction in COVID-19 patients: multivariate classification after sedation weaning
Multivariate classification of the presence or absence of brainstem dysfunction using support vector machine and extra-trees algorithm based on the EEG derived quantitative features presented above
Time frame: Day 4 to day 7 after sedation weaning.
Duration of mechanical ventilation
Time frame: at ICU discharge up to 28 days
Mortality
Time frame: at ICU discharge up to 28 days
Duration of hospitalisation
Time frame: at hospital discharge up to 90 days
Duration of coma, disturbance of consciousness, delirium
Time frame: at ICU discharge up to 28 days
Neurological functional evolution with mRankin
Using validated functional scale modified Rankin (mRankin) for independence assessment (mRankin ranges from 0 to 6 with higher scores indicating more severe disability)
Time frame: 90 days after inclusion
Neurological functional evolution with GOSE
Using validated functional scale Glasgow Outcome Scale Extended (GOSE) for independence assessment (GOSE ranges from 1 to 8 with higher scores indicating less severe disability outcome)
Time frame: 90 days after inclusion