Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
研究概览
简要总结
Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.
详细描述
The aim of the study is to assess the potential of using motion and facial expression data to detect delirium in ICU patients by comparing motion and facial expression patterns in delirium and control groups. In this study, the investigators will use ActiGraph accelerometers to record each subject's movement patterns. Also, a processed video using a commercially available camera interfaces with a specialized program to identify patient facial expressions and movement patterns. A total of 60 participants will be enrolled with delirium, and 30 patients without delirium will be used as control group. Motion profiles will be compared in the motorically defined subgroups (hyperactive, hypoactive, normal) based on accelerometer and facial recognition data. Then, differences in facial expression, number of changes in postures, and percentage of time spent moving will be compared between motorically defined subgroups and in delirium and control groups. EMR data will also be used to assess the feasibility of detecting delirium by including additional information on related risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •(ICU Patients):
- •Intensive care unit patient
- •18 years of age or older
排除标准
- •(ICU Patients):
- •Anticipated intensive care unit stay less than one day
- •Less than 18 years of age
- •Inability to wear a motion sensor watch (ActiGraph)
- •Inclusion Criteria (Healthy Controls):
- •18 years of age or older.
- •sleeps in home environment
- •Exclusion Criteria (Healthy Controls):
- •does not sleep in home environment
- •Less than 18 years of age
- •Inability to wear a motion sensor watch (ActiGraph)
结局指标
主要结局
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
时间窗: Changes from Baseline up to 7 Days
MDAS denotes motor profile and defines motor subtyping. It has 10 items which assesses several areas of cognitive functioning (memory, attention, orientation and disturbances in thinking) and psychomotor activity. The items are rated on a four point scale (0-3) based on the current interaction with the patient or by assessment of behavior. A score of 13 shows the diagnosis of delirium.
CAM/CAM-ICU
时间窗: Changes from Baseline up to 7 Days
Confusion Assessment Method for detection of delirium
Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.
时间窗: Changes from Baseline up to 7 Days
Scoring from DMSS-4 which has 5 hyperactive and 8 hypoactive symptoms requires at least two symptoms to be present from either the hyperactive or hypoactive list to meet subtype criteria. The higher the score the higher the delirium.
Freedman Sleep Scale
时间窗: Changes from Baseline up to 7 Days
To determine sleep quality of patient for given day.
次要结局
- Number of subjects on mechanical ventilation(greater than 48 hours)
- Number of subjects who died(Baseline up to 7 Days)