跳至主要内容
临床试验/NCT04589169
NCT04589169Unknown不适用

Continuous Non-Invasive Eye Tracking for the Early Detection of Delirium on the Intensive Care Unit

Chelsea and Westminster NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Demonstrate eye gaze correlates with CAM-ICU

研究概览

简要总结

In this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of CAM-ICU in a small representative sample of patients in the Intensive Care Unit (ICU) at Chelsea & Westminster NHS Foundation Trust.

详细描述

Delirium is an acute confusional state that affects many patients admitted to the hospital, especially intensive care. The current diagnosis of delirium is through the use of the Confusional Assessment Method in Intensive Care Unit (CAM-ICU) task based questionnaire. The core prinicipal to CAM-ICU is inattention; this is tested through asking the patient to remember a task and execute it on demand, e.g. squeezing the operator's hand everytime the letter A is said and then spelling CASABLANCA.

The aim of this study is to find correlates to inattention. Eye-gaze data is ideally suited for this task as eyes move to pay attention to the environment.

A video camera based eye-tracker has been developed that sits at the end of the bed (head-camera) and another behind the patient (scene-camera). The head-camera uses machine learning to measure the gaze of the patient's eyes while the scene-camera finds what the patient is looking at. Simulations are then run from the scene camera and the patient's gaze is then compared to find whether the patient is paying attention to what is simulated.

Once per day, a member of the local research team will fill in a non-validated questionnaire based on work by MacMurchy et al.

M. MacMurchy, S. Stemler, M. Zander, C. P. Bonafide, Acceptability, Feasibility, and Cost of Using Video to Evaluate Alarm Fatigue, Biomedical Instrumentation & Technology 51 (2017) 25-33.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Predicted Delirium as defined by the Early PREdiction of DELIRium in ICU patients (E-PREDELIRIC) score ≥ 20%
  • Expected length of stay ≥ 2 days

排除标准

  • Non-concordant eyes
  • Visual Impairment
  • Inability for facial recognition and eye tracking to be performed reliably
  • Lack of signed consent form / nominated consultee form
  • In-ability to perform CAM-ICU reliably

结局指标

主要结局

Demonstrate eye gaze correlates with CAM-ICU

时间窗: 8-12 months

Patient's usual clinical care will not be affected by the assessments performed by this study. In our institution, CAM-ICU is performed at least twice daily and more so if there are changes to mental status. The system will be switched on 5 minutes prior to performing CAM-ICU and will record for a duration of 10 minutes following which, the system will be turned off and the cameras covered. This procedure will occur every time CAM-ICU is performed.

次要结局

  • Acceptance of the use of cameras and artificial intelligence on ICU(8-12 months)

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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