NCT05127265

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
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Pain
• Delirium
• Confusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-24
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-11-19
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States