VR for ICU Delirium Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- Incidence of ICU Delirium
研究概览
简要总结
The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center
- •Expected ICU stay >48 hours
- •Richmond Agitation Sedation Scale (RASS) score between -1 to +
- •CAM-ICU negative
- •1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score >5, history of alcohol or benzodiazepine abuse, recent major surgery)
排除标准
- •Unwilling and/or unable to participate
- •Intubation of tracheostomy
- •Self-reported history of severe motion sickness
- •Inability to follow commands (e.g. severe aphasia, deafness, GCS<13)
- •The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted device (HMD
- •Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses
- •Having had a seizure in the past year
- •Unable to understand the instructions or to consent to participation in the study.
- •Those who are pregnant
- •Hemodynamic instability (MAP<65 despite support)
- •End-of-life care
- •Severe agitation or delirium (i.e. CAM-ICU + screen)
研究组 & 干预措施
Standard ICU delirium prevention
Study ICU Delirium Prevention and VR treatment
干预措施: Virtual Reality therapeutics (Device)
结局指标
主要结局
Incidence of ICU Delirium
时间窗: From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.
Using the CAM-ICU assessment, patients will be evaluated for the development of ICU delirium
次要结局
- Duration of ICU delirium(From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.)
- ICU-LOS(From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.)
- H-LOS(From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.)
- Acceptability by patients(From time enrolled in the study until the patient has completed the study interventions (either on discharge from the ICU or after 5 days of interventions, whichever comes first), from Day 1 until Day 5 after enrollment.)
- Number of adverse events(Adverse events related to VR, such as nausea, dizziness, seizures, will be assessed from the time of enrollment in the study up until the time of discharge from the hospital, from time of enrollment on Day 1 until Day 5 after enrollment, if applicable.)
研究者
Devon Callahan
Principal Investigator
Cedars-Sinai Medical Center