Wearable Eye-Tracking Device as Means of Communication in the Critically Ill and Mechanically Ventilated Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants Who Succeeded in Operating the EyeControl Device
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated. The study will assess the safety, tolerability, and ease of use of the EyeControl device, and examine its potential monitoring capabilities.
详细描述
Critically ill patients, who are mechanically ventilated, suffer not only from their acute, potentially devastating illness, but also from the lack of ability to communicate in an effective manner. This is the direct result of the orotracheal tube or tracheostomy required for the mechanical ventilation, which does not allow speech to be produced. On top of the mechanical change in air flow, communication challenges result from sedation, neurological injuries (primary brain injury or secondary encephalopathy), and delirium.
Lack of communication can lead to increased frustration, anxiety, and overall psychological stress and could continue to the development of post-traumatic stress disorder (PTSD). On top of the subjective discomfort, the inability to communicate in an effective manner may impair medical care-for example, by failure to assess symptoms such as pain or breathing discomfort by behavioral cues only.
Currently, the solutions for communication deficits in mechanically ventilated patients are mainly using yes/no communication, attempting to write, and communication boards that allow people to point at defined pictures or letters. Recently, technological advancements led to incorporation of more sophisticated communication devices, proving the feasibility of an eye-tracking approach, for example.
The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. This approach eliminates the need for calibration, as most eye-tracking devices that use a screen require, and is relatively easy to operate.
This study will assess the safety, tolerability, and ease of use of the EyeControl device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Intensive Care Unit (ICU) Admission
- •Mechanically ventilated for at least 24 hours
- •Richmond Agitation Sedation Score (RASS) between -1 to 1 at the time of screening
- •Ability to follow simple commands
排除标准
- •Inability to follow commands during screening (at a minimum: open and close eyes, move eyes to one side or the other)
- •Known cerebral injury (acute or chronic) in the dominant hemisphere concerning for aphasia on clinical assessment
- •Significant pre-existing neurologic (i.e., dementia and/or cognitive deficiencies), psychiatric, or baseline communication challenges that would confound outcomes assessments
- •Inability to blink or move eyes for any reason
- •Prisoner or incarceration
- •Inability or unwillingness to provide informed consent
- •Unwillingness to be contacted for follow-up
结局指标
主要结局
Number of Participants Who Succeeded in Operating the EyeControl Device
时间窗: Up to Day 3
Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days.
Number of Participants Successfully Operating the EyeControl Device Per Attempt Day
时间窗: Up to Day 3
Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The study day when participants passed the proficiency test was documented.
Time To Successful Operation of the EyeControl Device
时间窗: Up to Day 3
Successful operation of the device was defined as completing a set of assignments termed as a proficiency test. This proficiency test included the ability to call for help and the ability to choose a correct answer out of multiple choice questions that were read to the patient using the device. Participants were able to try to learn to operate the device once per day for up to three days. The time (in minutes) of training required for a patient to successfully operate the device was documented.
次要结局
- Days of Use(Up to end of study participation (up to 3 days))
研究者
Ofer Sadan
Assistant Professor
Emory University