Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Communication difficulty
研究概览
简要总结
The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). The main questions it aims to answer are:
Does the eye tracking interactive agent alleviate communication impairments among non-verbal patients in the ICU? Does the eye tracking interactive agent improve communication efficiency among non-verbal patients in the ICU? Does the eye tracking interactive agent m reduce the incidence of negative emotions among non-verbal patients in the ICU? Does the eye tracking interactive agent shorten the ICU length of stay for non-verbal patients in the ICU? Does the eye tracking interactive agent reduce the dosage of analgesic and sedative medications for non-verbal patients in the ICU? Does the eye tracking interactive agent improve family satisfaction for non-verbal patients in the ICU? Does the eye tracking interactive agent alleviate nurses' communication burden among non-verbal patients in the ICU? Researchers will compare eye tracking interactive agent to conventional techniques to see if e eye tracking interactive agent works to alleviate communication impairments.
Participants will:
Use an eye tracking interactive agent for augmentative communication for 2 consecutive days Document each communication's details, ICU LOS, and analgesic-sedative dosages; assess communication difficulty severity, delirium, anxiety, family satisfaction and nurses' communication burden with validated scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Aged ≥ 18 years
- •Patients in the ICU who are unable to communicate through normal verbal means due to endotracheal intubation/tracheotomy, muscle or nerve injury, acute/chronic spinal cord injury, etc.
- •Richmond Agitation-Sedation Scale (RASS) score of -1 to 1
- •Primary caregivers are adults
- •Able to read Chinese characters and follow simple commands
- •Willing to participate in this study.
排除标准
- •Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause
- •A history of mental disorders, dementia or pre-dementia, or intellectual disability
- •Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.
研究组 & 干预措施
eye-tracking group
干预措施: eye-tracking interactive agent (Device)
conventional techniques group
干预措施: conventional techniques (Other)
结局指标
主要结局
Communication difficulty
时间窗: up to 2days after enrollment
The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al. in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties.
次要结局
- Length of ICU stay(through discharge from the ICU，an average of 1 week)
- Physiological outcomes (blood pressure)(up to 2 days after enrollment)
- Communication efficiency(up to 2 days after enrollment)
- Anxiety(at 4:00 PM daily)
- Delirium-free days(through discharge from the ICU，an average of 1 week)
- Physiological outcomes (heart rate)(up to 2 days after enrollment)
- Dosage of analgesic and sedative medications(up to 2 days after enrollment)
- Satisfaction of primary caregivers(through discharge from the ICU，an average of 1 week)
- Communication burden of medical staffs(through study completion，an average of 1 year)
研究者
Shining Cai
charge nurse
Shanghai Zhongshan Hospital