Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05127265

Conditions

Critical Illness

Pain

Delirium

Confusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Video Monitoring

Accelerometer Monitoring

Noise Level Monitoring

Light Level Monitoring

Air Quality Monitoring

Study Details

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.

Conditions

Critical Illness

Pain

Delirium

Confusion

Study ID

NCT05127265

Start date

May 24, 2021

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

adult ICU patients

adult patients aged 18 or older admitted to University of Florida Health Shands Gainesville ICU wards

Interventions

Video Monitoring

continuous video monitoring

Accelerometer Monitoring

continuous accelerometer monitoring of patient movements

Noise Level Monitoring

continuous environmental noise monitoring

Light Level Monitoring

continuous environmental light monitoring

Air Quality Monitoring

continuous environmental air quality monitoring

EKG Monitoring

continuous EKG monitoring

Vitals Monitoring

continuous vitals monitoring (heart rate, oxygen saturation)

Biosample Collection

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

Delirium Motor Subtyping Scale 4 (DMSS-4)

done daily on delirious patients to subtype delirium

Primary outcome measure

  • Algorithmic Activity Labeling [ Time Frame: Image frames collected continuously for up to 7 days maximum. ]
  • Algorithmic Pain Labeling [ Time Frame: Image frames collected continuously for up to 7 days maximum. ]
  • Decibel Levels [ Time Frame: Noise sensor data collected continuously for up to 7 days maximum. ]
  • Lux Levels [ Time Frame: Light sensor data collected continuously for up to 7 days maximum. ]
  • Air Quality [ Time Frame: Air quality sensor data collected continuously for up to 7 days maximum. ]
  • Circadian Dyssynchrony Index [ Time Frame: Change in internal circadian profile from Day 1 to Day 2. ]
  • Algorithmic Delirium Recognition Profile [ Time Frame: Data collected for up to 7 days maximum. ]
  • Delirium Motor Subtyping Scale 4 (DMSS-4) [ Time Frame: Changes from baseline up to a maximum of 7 days ]

Central Contacts and Locations

Central contacts

Andrea E Davidson, BS

352-294-8723adavidson@ufl.edu

Locations

University of Florida Health Shands Hospital

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Azra Bihorac, MD, MS

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.