Intelligent Intensive Care Unit

Delirium Clinical Trial

— ICU_Delirium  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02465307
• Other study ID #: IRB201400546 -N
• Secondary ID: 17501921R21EB027
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: May 30, 2025

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: May 30, 2025
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Confusion
• Delirium

Intervention

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
• Commercially available camera
As part of facial recognition video system
• Internet Pod (iPod)
Monitors noise levels in the room

Diagnostic Test:
• Cortisol Swab
Cortisol level collected through self administered salivary swab

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Neurological Disorders and Stroke (NINDS), U.S. National Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Dynamic activity versus static position	Percentage of time spent moving versus static position	Changes from Baseline up to 7 Days
Primary	CAM/CAM-ICU	Confusion Assessment Method for detection of delirium	Changes from Baseline up to 7 Days
Primary	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
Primary	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
Primary	Freedman Sleep Scale	To determine sleep quality of patient for given day.	Changes from Baseline up to 7 Days
Secondary	Number of subjects who died	Death at any time during admission	Baseline up to 7 Days
Secondary	Number of subjects on mechanical ventilation	Number of subjects requiring mechanical ventilation greater than 48 hours.	greater than 48 hours