NCT05127265 · University of Florida
Pervasive Sensing and AI in Intelligent ICU
What this study is about
Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all.
View original scientific description
Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all. Consequently, these important visual cues, although associated with critical indices such as physical functioning, pain, delirious state, and impending clinical deterioration, often cannot be incorporated into clinical status. The overall objectives of this project are to sense, quantify, and communicate patients' clinical conditions in an autonomous and precise manner, and develop a pervasive intelligent sensing system that combines deep learning algorithms with continuous data from inertial, color, and depth image sensors for autonomous visual assessment of critically ill patients. The central hypothesis is that deep learning models will be superior to existing acuity clinical scores by predicting acuity in a dynamic, precise, and interpretable manner, using autonomous assessment of pain, emotional distress, and physical function, together with clinical and physiologic data.
Interventions
OTHER
Video Monitoring
continuous video monitoring
OTHER
Accelerometer Monitoring
continuous accelerometer monitoring of patient movements
OTHER
Noise Level Monitoring
continuous environmental noise monitoring
OTHER
Light Level Monitoring
continuous environmental light monitoring
OTHER
Air Quality Monitoring
continuous environmental air quality monitoring
OTHER
EKG Monitoring
continuous EKG monitoring
OTHER
Vitals Monitoring
continuous vitals monitoring (heart rate, oxygen saturation)
OTHER
Biosample Collection
blood and urine samples collected once on Day 1 and once on Day 2
OTHER
Delirium Motor Subtyping Scale 4 (DMSS-4)
done daily on delirious patients to subtype delirium
Primary outcome measures
Algorithmic Activity Labeling
Time frame: Image frames collected continuously for up to 7 days maximum.
The algorithm's output will report on which activity the patient is performing in the corresponding image data.
Algorithmic Pain Labeling
Time frame: Image frames collected continuously for up to 7 days maximum.
The algorithm's output will report on whether the patient is experiencing pain in the corresponding image data.
Decibel Levels
Time frame: Noise sensor data collected continuously for up to 7 days maximum.
Determine relative decibel (noise loudness) levels in study patient's ICU room to alert for abnormalities in decibel level (noisiness of environment).
Lux Levels
Time frame: Light sensor data collected continuously for up to 7 days maximum.
Determine relative lux (light illumination) levels in study patient's ICU room to alert for abnormalities in illumination level.
Air Quality
Time frame: Air quality sensor data collected continuously for up to 7 days maximum.
Determines relative air quality pollution levels in study patient's ICU room to alert for abnormalities in room air quality.
Circadian Dyssynchrony Index
Time frame: Change in internal circadian profile from Day 1 to Day 2.
Blood and urine samples will be collected and processed to determine the presence of dyssynchrony in a subject's internal circadian clock.
Algorithmic Delirium Recognition Profile
Time frame: Data collected for up to 7 days maximum.
The algorithm's output will report on whether patient is likely to be delirious or at-risk of delirium based on activity, facial expression, and circadian dyssynchrony index data collected from study devices and biosamples.
Delirium Motor Subtyping Scale 4 (DMSS-4)
Time frame: Changes from baseline up to a maximum of 7 days
Determines which subtype of delirium a subject is experiencing. This subtyping scale has 13 symptom items (5 hyperactive and 8 hypoactive) derived from the 30-item Delirium Motor Checklist. To subtype a delirious subject, at least 2 symptoms are required to be present from either the hyperactive or hypoactive checklist to meet the subtyping criteria for 'hyperactive delirium' or 'hypoactive delirium'. Patients who meet both hyperactive and hypoactive criteria are determined as 'mixed subtype', while patients meeting neither hyperactive or hypoactive criteria are labeled as 'no subtype'.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- aged 18 or older
- admitted to UF Health Shands Gainesville ICU ward
- expected to remain in ICU ward for at least 24 hours at time of screening
Exclusion criteria
- under the age of 18
- on any contact/isolation precautions
- expected to transfer or discharge from the ICU in 24 hours or less
- unable to provide self-consent or has no available proxy/LAR
Where
- Gainesville, Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Related conditions & keywords
Frequently asked questions
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations