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Intelligent Intensive Care Unit

NCT ID: NCT02465307

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2028-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium Confusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium group

ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).

Confusion Assessment Method

Intervention Type BEHAVIORAL

Confusion Assessment Method (CAM) score

Accelerometer

Intervention Type DEVICE

3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor

Commercially available camera

Intervention Type DEVICE

As part of facial recognition video system

Internet Pod (iPod)

Intervention Type DEVICE

Monitors noise levels in the room

Control group

ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).

Confusion Assessment Method

Intervention Type BEHAVIORAL

Confusion Assessment Method (CAM) score

Accelerometer

Intervention Type DEVICE

3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor

Commercially available camera

Intervention Type DEVICE

As part of facial recognition video system

Internet Pod (iPod)

Intervention Type DEVICE

Monitors noise levels in the room

Healthy control group

Healthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod)

Accelerometer

Intervention Type DEVICE

3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor

Internet Pod (iPod)

Intervention Type DEVICE

Monitors noise levels in the room

Cortisol Swab

Intervention Type DIAGNOSTIC_TEST

Cortisol level collected through self administered salivary swab

Interventions

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Confusion Assessment Method

Confusion Assessment Method (CAM) score

Intervention Type BEHAVIORAL

Accelerometer

3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor

Intervention Type DEVICE

Commercially available camera

As part of facial recognition video system

Intervention Type DEVICE

Internet Pod (iPod)

Monitors noise levels in the room

Intervention Type DEVICE

Cortisol Swab

Cortisol level collected through self administered salivary swab

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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imaging Sound detection

Eligibility Criteria

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Inclusion Criteria

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


* 18 years of age or older.
* sleeps in home environment

Exclusion Criteria

* Anticipated intensive care unit stay less than one day
* Less than 18 years of age
* Inability to wear a motion sensor watch (ActiGraph)


* does not sleep in home environment
* Less than 18 years of age
* Inability to wear a motion sensor watch (ActiGraph)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. National Science Foundation

FED

Sponsor Role collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azra Bihorac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1750192

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R21EB027344-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01NS120924-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201400546 -N

Identifier Type: -

Identifier Source: org_study_id

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