NCT07485244招募中不适用
EEG Abnormalities in Adult ICU Patients With High Risk of Delirium
Ceribell Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月16日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of EEG Abnormalities on the Ceribell EEG System
研究概览
简要总结
The purpose of this study is to assess the prevalence of EEG abnormalities on Ceribell POC EEG in adult medical, surgical, and cardiovascular ICU patients with high risk of delirium
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
- •Adult patient ≥18 years old
- •Requiring admission to a medical, surgical and/or cardiovascular ICU for an expected duration ≥ 24 hours
- •Receiving treatment for shock (e.g., with vasopressors, intra-aortic balloon pump, or Extracorporeal Membrane Oxygenation therapy) and/or respiratory failure [e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)].
排除标准
- •Any structural abnormality or head condition, including the presence of a device, that would prevent the use of the Ceribell EEG system for the entire anticipated EEG monitoring period. Examples include: Craniectomy with a missing bone flap in a region where Ceribell EEG electrodes would be placed.
- •Anticipated use of continuous EEG for a purpose other than delirium detection during the entire expected monitoring period.
- •Patients who have been on mechanical ventilation for >72 hours within the current hospitalization or who are on long-term ventilator support prior to the injury that resulted in the current hospitalization.
- •Expected death within 12 hours of enrollment or lack of commitment to treatment by family or the medical team (e.g., likely to withdraw life support measures within 12 hours of enrollment).
- •Acute or chronic neurologic deficit precluding CAM-ICU assessments
- •Inability to understand English
- •Bilateral Deafness
- •Blindness that will preclude delirium evaluation
- •Current enrollment in a study that does not allow co-enrollment
- •Inability to obtain informed consent
- •Attending physician refusal
- •Patient and/or surrogate refusal
- •Patient unable to consent and no surrogate available
- •Prisoners
研究组 & 干预措施
Prospective Ceribell Delirium Monitoring
Enrolled patients will undergo EEG monitoring with the Ceribell EEG System twice daily for up to 7 days.
干预措施: Ceribell EEG System (Device)
结局指标
主要结局
Prevalence of EEG Abnormalities on the Ceribell EEG System
时间窗: Starting baseline through study completion, up to 1 year.
Prevalence of EEG abnormalities, including epileptiform and ictal-interictal continuum (IIC) patterns, recorded on the Ceribell EEG System
次要结局
未报告次要终点
研究者
研究点 (1)
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