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Pervasive Sensing and AI in Intelligent ICU

Pervasive Sensing and Artificial Intelligence in Intelligent ICU Subtitles: -Intelligent Intensive Care Unit (I2CU): Pervasive Sensing and Artificial Intelligence for Augmented Clinical Decision-making -ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05127265
Enrollment
400
Registered
2021-11-19
Start date
2021-05-24
Completion date
2026-12-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confusion, Critical Illness, Delirium, Pain

Keywords

Critical Illness, Pain, Delirium, Confusion, Patient Acuity, ICU, Acute Illness

Brief summary

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.

Detailed description

The under-assessment of pain is one of the primary barriers to the adequate treatment of pain in critically ill patients, and is associated with many negative outcomes such as chronic pain after discharge, prolonged mechanical ventilation, longer ICU stay, and increased mortality risk. Many ICU patients cannot self-report their pain intensity due to their clinical condition, ventilation devices, and altered consciousness. The monitoring of patients' pain status is yet another task for over-worked nurses, and due to pain's subjective nature, those assessments may vary among care staff. These challenges point to a critical need for developing objective and autonomous pain recognition systems. Delirium is another common complication of patient hospitalization, which is characterized by changes in cognition, activity level, consciousness, and alertness and has rates of up to 80% in surgical patients. The risk factors that have been associated with delirium include age, preexisting cognitive dysfunction, vision and hearing impairment, severe illness, dehydration, electrolyte abnormalities, overmedication, alcohol abuse, and disruptions in sleep patterns. Estimates show that about one third of delirium cases can benefit from drug and non-drug prevention and intervention. However, detecting and predicting pain and delirium is still very limited in practice. The aim of this study is to evaluate the ability of the investigators' proposed model to leverage accelerometer, environmental, circadian rhythm biomarkers, and video data in autonomously quantifying pain, characterizing functional activities, and delirium status. The Autonomous Delirium Monitoring and Adaptive Prevention (ADAPT) system will use novel pervasive sensing and deep learning techniques to autonomously quantify patients' mobility and circadian dyssynchrony in terms of nightly disruptions, light intensity, and sound pressure level. This will allow for the integration of these risk factors into a dynamic model for predicting delirium trajectories. Commercially available cameras will be used to monitor patients' facial expressions and contextualize patients' actions by providing imaging data to provide additional patient movement information. Commercially available environmental sensors will be used to provide data on illumination, decibel level, and air quality. Patient blood samples will help determine their circadian rhythm and compare and validate the pervasive sensing system's capabilities of autonomously monitoring circadian dyssynchrony. Electronic health record data will also be collected.

Interventions

continuous video monitoring

continuous accelerometer monitoring of patient movements

continuous environmental noise monitoring

continuous environmental light monitoring

OTHERAir Quality Monitoring

continuous environmental air quality monitoring

OTHEREKG Monitoring

continuous EKG monitoring

OTHERVitals Monitoring

continuous vitals monitoring (heart rate, oxygen saturation)

blood and urine samples collected once on Day 1 and once on Day 2

OTHERDelirium Motor Subtyping Scale 4 (DMSS-4)

done daily on delirious patients to subtype delirium

Sponsors

University of Florida
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Algorithmic Activity LabelingImage 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 LabelingImage 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 LevelsNoise 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 LevelsLight 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 QualityAir 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 IndexChange 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 ProfileData 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)Changes from baseline up to a maximum of 7 daysDetermines 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'.

Secondary

MeasureTime frameDescription
MortalityFrom baseline (study enrollment) up to a maximum of 7 daysStatus of alive or deceased

Countries

United States

Contacts

CONTACTAndrea E Davidson, BS
adavidson@ufl.edu352-294-8723
PRINCIPAL_INVESTIGATORAzra Bihorac, MD, MS

University of Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026