Delirium Clinical Trial
— ICU_DeliriumOfficial title:
Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
Verified date | June 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | UF Health | Gainesville | Florida |
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 |
United States,
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 |
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