Intelligent Intensive Care Unit (ICU_Delirium)

Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium; Confusion
• Intervention / Treatment: Behavioral: Confusion Assessment Method; Device: Accelerometer; Device: Commercially available camera; Device: Internet Pod (iPod); Diagnostic test: Cortisol Swab

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 Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Andrea E Davidson, BS; Phone Number: 352-294-8723; Email: adavidson@ufl.edu
• Study Contact Backup: Name: Brooke Armfield, PhD; Phone Number: 352-294-8580; Email: barmfield@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

ICU Patients: Patients who been hospitalized in an intensive care unit and have risk factors to develop delirium or delirium has been suspected by their medical provider.

Healthy Controls: People who are healthy and sleep in their home environment.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Delirium group; ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).	Behavioral: Confusion Assessment Method; Confusion Assessment Method (CAM) score; Device: Accelerometer; 3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor; Device: Commercially available camera; As part of facial recognition video system; Other Names: imaging; Device: Internet Pod (iPod); Monitors noise levels in the room; Other Names: Sound detection
Control group; ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).	Behavioral: Confusion Assessment Method; Confusion Assessment Method (CAM) score; Device: Accelerometer; 3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor; Device: Commercially available camera; As part of facial recognition video system; Other Names: imaging; Device: Internet Pod (iPod); Monitors noise levels in the room; Other Names: Sound detection
Healthy control group; Healthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod)	Device: Accelerometer; 3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor; Device: Internet Pod (iPod); Monitors noise levels in the room; Other Names: Sound detection; Diagnostic test: Cortisol Swab; Cortisol level collected through self administered salivary swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAM/CAM-ICU	Confusion Assessment Method for detection of delirium	Changes from Baseline up to 7 Days
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.	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.	Changes from Baseline up to 7 Days
Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.	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.	Changes from Baseline up to 7 Days
Freedman Sleep Scale	To determine sleep quality of patient for given day.	Changes from Baseline up to 7 Days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial amimia versus non-amimia expressions between the groups	Frequency of presence of facial amimia versus non-amimia expressions between the groups.	Changes from Baseline up to 7 Days
Dynamic activity versus static position	Percentage of time spent moving versus static position	Changes from Baseline up to 7 Days

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institute for Biomedical Imaging and Bioengineering (NIBIB); U.S. National Science Foundation
• Investigators: Principal Investigator: Azra Bihorac, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): March 11, 2020
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimated): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Posture; Intensive care unit; Cognition; Delirium; Alertness; Consciousness; Activity level; Hyperactive delirium; Hypoactive delirium; Facial expression
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Confusion; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: IRB201400546 -N; 1750192 (Other Grant/Funding Number: National Science Foundation); 1R21EB027344-01 (U.S. NIH Grant/Contract); R01NS120924-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No