Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Patient discomfort (per discretion of the bedside nurse)
研究概览
简要总结
This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience
详细描述
Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.
Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for >= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period
Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.
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
- •Adults ≥18
- •Blunt TBI with Glasgow Coma Score (GCS) ≤8
- •Injury within 72 hours
- •Adequate TCD windows
- •Ability to obtain informed consent from a Legally Authorized Representative (LAR)
排除标准
- •Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
- •C- spine fracture with evidence of spinal cord injury
- •Severe skull or scalp injury precluding device placement
- •Planned decompressive hemicraniectomy
- •Continuous fever for >6 hours at the time of enrollment (despite treatment)
- •Lack of TCD window
结局指标
主要结局
Patient discomfort (per discretion of the bedside nurse)
时间窗: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe
Inadvertent dislodgement of other intracranial monitoring device/s (if present)
时间窗: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Skin changes associated with TCD
时间窗: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.
时间窗: 2 years
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety of protocol implementation.
Evaluation of adequate temporal windows
时间窗: 2 years
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Evaluation of adequate insolation of middle cerebral arteries (MCA)
时间窗: 2 years
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population
时间窗: 2 years
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.
次要结局
未报告次要终点