Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.
详细描述
The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.
To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:
- SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
- MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.
Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.
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 admitted to the ICU
- •ARDS confirmed according to the Berlin Definition
- •Invasive mechanical ventilation
- •Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team
- •Application of monitoring devices feasible
排除标准
- •More than 24 hours elapsed since ICU admission
- •Death is deemed imminent and inevitable during the next 24 hours
- •Known allergy to a textile component of the device
- •Consent declined from patient or authorized third party
- •The treating clinician believes that participation in the study would not be in the best interest of the patient
结局指标
主要结局
Recruitment
时间窗: 20 months
Recruitment of two patients per month, allowing for seasonal variation in ARDS.
Data Quality
时间窗: 7 days
Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt
次要结局
- SEDopt(7 days)
- MAPopt(7 days)
研究者
Asher Mendelson
Assistant Professor
University of Manitoba