Monitoring of Cerebral Oxygenation Using Jugular Oximetry in Comatose Patients After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oxygen Saturation of Jugular Venous Bulb
研究概览
简要总结
The use of protective ventilation (to maintain normoxia and normocapnia), optimise haemodynamics, diagnose/treat seizures, therapeutic hypotermia etc is recommended for ICU management of patients who have had cardiac arrest and remain in coma after return of spontaneous circulation according to the latest International Guidelines. These actions essentially aim to limit secondary brain injury but despite all therapeutic effort, the cerebral oxygenation may remain inadequate and there is no validated method to avoid such a state in real time.
详细描述
The use of protective ventilation (to maintain normoxia and normocapnia), optimize hemodynamics, diagnose/treat seizures, therapeutic hypothermia etc is recommended for ICU management of patients who have had cardiac arrest and remain in a coma after the return of spontaneous circulation according to the latest International Guidelines. These actions essentially aim to limit secondary brain injury but despite all therapeutic effort, the cerebral oxygenation may remain inadequate and there is no validated method to avoid such a state in real time.
The objective of this study is to assess the relationship between jugular venous oximetry and neurological outcome of comatose patients after cardiac arrest, evaluated as per the Cerebral Performance Category scale (CPC). Further, the aim is to clarify relations between biomarkers protein S100B, neuron-specific enolase (NSE) and parameters of jugular oximetry for prognostication. An anticipated total of sixty patients will be enrolled in this non-randomised, single-group, double-blind study.
In the course of the study, the authors have decided to stop using BIS monitoring for sedation management. Reason for this decision was very limited reliability of this technique in unparalyzed patients on ICU (muscle artifacts). New aim of sedation was Richmond Agitation Sedation Scale (RASS) -4 or -5, with avoiding shivering and clinically manifested seizures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •age 18 or older
- •successful cardiopulmonary resuscitation
- •persistent coma defined as: no eye opening to voice and inability to follow commands
排除标准
- •pre-existing "do not resuscitate" status
- •severe coexisting systemic disease with a limited life expectancy
- •pregnancy
- •patients who will die within 72 h of the initial cardiac arrest
结局指标
主要结局
Oxygen Saturation of Jugular Venous Bulb
时间窗: 24 months
The saturation of oxygen will be monitored after admission to ICU and every 6 hours for the total period of 72 hour after cardiac arrest
Serum S100B level
时间窗: 24 months
The serum S100B level will be monitored after admission of the patients to ICU
Serum NSE level
时间窗: 24 months
The serum NSE level will be monitored after admission of the patient to ICU and 24, 48 and 72 hour after cardiac arrest
BIS monitor guided sedation to level 40-60
时间窗: 24 months
BIS monitor-guided sedation with the aim of achieving the level of 40-60 will be maintained for 36 hour after admission of the patients to ICU
次要结局
- Functional status(24 months)
