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Intelligent Intensive Care Unit (ICU_Delirium)

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University of Florida

Status

Active, not recruiting

Conditions

Delirium
Confusion

Treatments

Device: Accelerometer
Device: Internet Pod (iPod)
Diagnostic Test: Cortisol Swab
Device: Commercially available camera
Behavioral: Confusion Assessment Method

Study type

Observational

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT02465307
R01NS120924-01 (U.S. NIH Grant/Contract)
1750192 (Other Grant/Funding Number)
1R21EB027344-01 (U.S. NIH Grant/Contract)
IRB201400546 -N

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (ICU Patients):

  • Intensive care unit patient
  • 18 years of age or older

Exclusion Criteria (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)

Trial design

130 participants in 3 patient groups

Delirium group
Description:
ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).
Treatment:
Behavioral: Confusion Assessment Method
Device: Commercially available camera
Device: Internet Pod (iPod)
Device: Accelerometer
Control group
Description:
ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).
Treatment:
Behavioral: Confusion Assessment Method
Device: Commercially available camera
Device: Internet Pod (iPod)
Device: Accelerometer
Healthy control group
Description:
Healthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod)
Treatment:
Diagnostic Test: Cortisol Swab
Device: Internet Pod (iPod)
Device: Accelerometer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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