Health TrialsbyHealthPanel

Pervasive Sensing and AI in Intelligent ICU

ConditionsCritical IllnessPainDeliriumConfusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Critically ill adults, aged 18 and over, admitted to UF Health Shands Gainesville ICU wards

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Video Monitoring

    Other intervention

    continuous video monitoring

  • Accelerometer Monitoring

    Other intervention

    continuous accelerometer monitoring of patient movements

  • Noise Level Monitoring

    Other intervention

    continuous environmental noise monitoring

  • Light Level Monitoring

    Other intervention

    continuous environmental light monitoring

  • Air Quality Monitoring

    Other intervention

    continuous environmental air quality monitoring

  • EKG Monitoring

    Other intervention

    continuous EKG monitoring

  • Vitals Monitoring

    Other intervention

    continuous vitals monitoring (heart rate, oxygen saturation)

  • Biosample Collection

    Other intervention

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

  • Delirium Motor Subtyping Scale 4 (DMSS-4)

    Other intervention

    done daily on delirious patients to subtype delirium

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: adult ICU patients9 interventions

Trial outcomes

Primary outcomes

1

Algorithmic Activity Labeling

The algorithm's output will report on which activity the patient is performing in the corresponding image data.

Time frame
Image frames collected continuously for up to 7 days maximum.
2

Algorithmic Pain Labeling

The algorithm's output will report on whether the patient is experiencing pain in the corresponding image data.

Time frame
Image frames collected continuously for up to 7 days maximum.
3

Decibel Levels

Determine relative decibel (noise loudness) levels in study patient's ICU room to alert for abnormalities in decibel level (noisiness of environment).

Time frame
Noise sensor data collected continuously for up to 7 days maximum.
4

Lux Levels

Determine relative lux (light illumination) levels in study patient's ICU room to alert for abnormalities in illumination level.

Time frame
Light sensor data collected continuously for up to 7 days maximum.

Secondary outcomes

1

Mortality

Status of alive or deceased

Time frame
From baseline (study enrollment) up to a maximum of 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
Apply now