Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To determine the sedation levels of patients during paralysis
研究概览
简要总结
"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •"Patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours."
排除标准
- •Patients under 18 years of age,
- •pregnant individuals
- •trauma patients,
- •intracerebral pathology
- •major bleeding
- •central nervous system diseases,
- •pre-existing poor neurological condition before admission to the intensive care unit,
- •inability to document continuous neuromuscular blocking agent infusion for at least 24 hours."
结局指标
主要结局
To determine the sedation levels of patients during paralysis
时间窗: For patients undergoing therapeutic paralysis, over a 24-hour period,"
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
The prevalence of inadequate or excessive sedation,
时间窗: For patients undergoing therapeutic paralysis, over a 24-hour period,"
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
次要结局
- Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),(The assessment process conducted immediately before the application of paralysis.")
研究者
Aykut Saritas
associated professor
Tepecik Training and Research Hospital