Intelligent Intensive Care Unit

Active, not recruiting

• Conditions: Delirium; Confusion
• Interventions: Behavioral: Confusion Assessment Method; Device: Accelerometer; Diagnostic Test: Cortisol Swab; Device: Commercially available camera; Device: Internet Pod (iPod)

• Registration Number: NCT02465307
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Study Start: 2016-02
• Primary Completion: 2020-03-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.	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	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.	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	Changes from Baseline up to 7 Days	To determine sleep quality of patient for given day.

Secondary Outcome Measures

Name	Time	Method
Number of subjects on mechanical ventilation	greater than 48 hours	Number of subjects requiring mechanical ventilation greater than 48 hours.
Number of subjects who died	Baseline up to 7 Days	Death at any time during admission

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States