Non-invasive Continuous Hemodynamic Monitoring in Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- functional outcomes
研究概览
简要总结
The goal of this observational study is to explore the relationship of heart function with the course and outcomes after traumatic brain injuries and nontraumatic intracerebral hemorrhage. The goal is to explore association between routinely collected hemodynamic and brain monitoring data.
Participants already taking intervention A as part of their regular medical care and the investigators will follow up with participants 6 months after discharging the hospital.
详细描述
This is a prospective observational study collecting data produced as part of standard routine clinical care and the study team will collect the data from Starling Monitor and subject medical record. Adult patients undergoing hemodynamic monitoring with the Starling monitor as part of their standard of care will be considered as a candidate for the study. Patients will only be included in this study if they agree to take part in the data collection. If the patient declines participation, they will still undergo hemodynamic monitoring with the Starling hemodynamic monitor, but their clinical and Starling device information will not be collected to be entered into the database.
No clinical interventions are part of the study. There is no interference of data collected with clinical decision making. Hemodynamic data will be derived via the application of the entirely non-invasive, FDA approved for clinical use, Starling System (provided by Baxter for this study).
Prior to enrollment, the study team will provide patients and/or their family members the details of the study, answer any questions and address concerns. The patient and/or their families will then be given time to consider participation. After informed consent is obtained from the patient or legally authorized representative, patient data will be extracted from the electronic medical record (EMR) into a REDCap database and Case Report Forms (CRFs).
The study team also will collect the data from the Starling Monitor and subject's medical record.
Data collection:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are:
- •Admitted to the University of Chicago Medical Center Neurocritical Care Unit
- •Adults between 18 years and 80
- •Admitted with Traumatic brain injury blunt and penetrating or nontraumatic intracerebral hemorrhage
- •post-resuscitation Glasgow Coma Scale (GCS) <9
排除标准
- •Patients who were:
- •Pre-existing heart failure
- •Moribund or neurological exam suggesting imminent brain death (bilateral, fixed and dilated pupils) on admission
- •Major polytrauma or admitted to the surgical trauma critical care service
结局指标
主要结局
functional outcomes
时间窗: 180 days after discharging the hospital
Primary endpoints are functional outcomes and quality of life at 180 days after hospital discharge. The follow-up functional status and quality of life measures will be done by telephone, in-person at their regularly scheduled follow-up appointment, or by email, for less than 30 minutes using validated instruments and/or using a web-based REDCap survey. However, these surveys can also be completed during the subject's 180-day follow up visit with their doctor or a telephone follow-up. The follow up telephone call/visit will last for less than 30 minutes and will consist of a series of validated instruments/questionnaires. The following instruments will be used: Glasgow Outcome Scale Extended (GOSE) to ascertain functional status The GOSE score ranges from 1 to 8, with the minimum score of 1 indicating Death and the highest score of 8 representing a Good Recovery, signifying a good outcome and a return to pre-injury functioning.
次要结局
未报告次要终点