Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Subjective Experiential Outcome After ICU Admission
研究概览
简要总结
The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline normal neurological function pre-operatively.
- •Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.
排除标准
- •Chronic dementia, Alzheimer's disease, or other chronic neurological disease (i.e., Bi-Polar).
- •Chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics.
- •Patient undergoing emergent surgery.
- •Use of post-operative cardiopulmonary support devices such as ECMO (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.
结局指标
主要结局
Subjective Experiential Outcome After ICU Admission
时间窗: Once, up to 3 days after transfer out of the Intensive Care Unit.
Survey questions to understand patient's subjective experience in the intensive care unit. The number of subjects who completed the survey.
Confusion Assessment Method for the ICU (CAM-ICU)
时间窗: Once, during ICU admission within 24 hours of ICU admission.
Number of Participants with one or more Positive Confusion Assessment. "Confusion Assessment Method for the ICU" - Establishes ability to detect delirium in high-risk settings such as the intensive care unit. Recorded during every scheduled patient assessment by nurse and with mental changes. Reports as "Positive" or "Negative" with response to different assessments regarding level of consciousness, acute onset or fluctuating course of mental status and inattention.
Subjective Experiential Outcome After ICU Simulation
时间窗: Once, immediately following the virtual reality ICU simulation session.
Survey questions to understand patient's subjective experience during the virtual reality ICU simulation session. Internally created survey. The number of subjects who completed the survey.
次要结局
- Duration of ICU Admission(During ICU admission; average 2 days)
- Duration of Intravenous Sedation in the ICU(During ICU admission; average 2 days)
- Duration of Mechanical Ventilation in the ICU(During ICU admission; average 2 days)
- Use of Anti-psychotic Medications(Throughout ICU admission; average of 5 days)
- Cardiopulmonary Bypass(During OR case; average 12 hours)
研究者
Robert (Bobby) J. Anderson
Principal Investigator
Mayo Clinic