Brainstem Dysfunction in Ventilated and Deeply Sedated COVID-19 Critically Ill Patients: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Brainstem dysfunction prevalence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU hospitalization
- •Invasive mechanical ventilation
- •Deep sedation (RASS<-3) >12 hours
- •Positive SARS-COV-2 PCR
排除标准
- •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
研究组 & 干预措施
group 1
Major patients, admitted in intensive care for a SARS-CoV-2 infection and requiring mechanical ventilation and deep sedation (with or without neuromuscular blockade)
干预措施: Brainstem Responses Assessment Sedation Score (BRASS) (Diagnostic Test)
group 1
Major patients, admitted in intensive care for a SARS-CoV-2 infection and requiring mechanical ventilation and deep sedation (with or without neuromuscular blockade)
干预措施: Electroencephalogram with EKG lead (Diagnostic Test)
结局指标
主要结局
Brainstem dysfunction prevalence
时间窗: At inclusion or in patients with neuromuscular blockade 12h-72h following neuromuscular blocking agent cessation
Clinical cranial nerves anomalies using validated scale (BRASS score- ranges from 0 to 7 - ) in deeply sedated patient (RASS \<-3)
次要结局
- 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 functional connectivity, after sedation weaning(Day 4 to day 7 after sedation weaning.)
- Characterization of brainstem dysfunction in COVID-19 patients: EEG complexity after sedation weaning(Day 4 to day 7 after sedation weaning.)
- Characterization of brainstem dysfunction in COVID-19 patients: EEG functional connectivity(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(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.)
- Duration of mechanical ventilation(at ICU discharge up to 28 days)
- 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: multivariate classification(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(Day 4 to day 7 after sedation weaning.)
- Duration of coma, disturbance of consciousness, delirium(at ICU discharge up to 28 days)
- Neurological functional evolution with mRankin(90 days after inclusion)
- Neurological functional evolution with GOSE(90 days after inclusion)
- Mortality(at ICU discharge up to 28 days)
- Duration of hospitalisation(at hospital discharge up to 90 days)