Clinical trial NCT02465307: Intelligent Intensive Care Unit
Official title: Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Delirium
Confusion
Keywords: Consciousness
Alertness
Cognition
Activity level
Delirium
Hyperactive delirium
Hypoactive delirium
Facial expression
Posture
Intensive care unit
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2015-06-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: CAM/CAM-ICU
timeFrame: Changes from Baseline up to 7 Days
measure: Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
timeFrame: Changes from Baseline up to 7 Days
measure: Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.
timeFrame: Changes from Baseline up to 7 Days
measure: Freedman Sleep Scale
timeFrame: Changes from Baseline up to 7 Days
Secondary outcomes:
measure: Number of subjects who died
timeFrame: Baseline up to 7 Days
measure: Number of subjects on mechanical ventilation
timeFrame: greater than 48 hours
Other outcomes:
measure: Facial amimia versus non-amimia expressions between the groups
timeFrame: Changes from Baseline up to 7 Days
measure: Dynamic activity versus static position
timeFrame: Changes from Baseline up to 7 Days
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Azra Bihorac, MD
role: PRINCIPAL_INVESTIGATOR
References: