Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients with Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Delirium Day
研究概览
简要总结
The goal of this clinical trial is to learn the effect of VR-based Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is:
·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?
Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes.
Participants will:
- Receive the VRFS intervention until the endotracheal tube (ETT) is removed.
- Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure.
- Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.
详细描述
During the VRFS interventions, researchers will fit participants with a VR headset and noise-canceling headphones, shielding them from the ICU environment while allowing family members to be present and offer companionship and comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical ventilation duration is expected to be greater than 24 hours;
- •ICU stay duration is expected to be greater than 72 hours;
- •Age is 18 years or older, with no upper age limit;
- •Language: Chinese.
排除标准
- •Severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness);
- •Cognitive and consciousness disturbances prior to ICU admission;
- •Severe motion sickness;
- •Head trauma or surgery that prevents the wearing of equipment;
- •A history of long-term use of antipsychotic and/or benzodiazepine medications.
研究组 & 干预措施
VRFS Intervention
Participants will receive standard ICU care and will also undergo VRFS intervention.
干预措施: VRFS (Device)
Standard ICU Care
Patients will be treated with standard ICU care and not receive VR stimulation.
结局指标
主要结局
Delirium Day
时间窗: 2 years
Delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive.
次要结局
- ICU Days(2 years)
- Duration of Mechanical Ventilation(2 years)
- Electroencephalogram (EEG)(2 years)
- Oxygen saturation level(2 years)
- Blood pressure(2 years)
- Dosage of sedative and analgesic drugs(2 years)