跳至主要内容
临床试验/NCT05525702
NCT05525702招募中不适用

Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients with Mechanical Ventilation

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年12月18日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

VR Interventions to Reduce the Prevalence of... | 临床试验