PainNCT03905668
Fundamental Intelligent Building Blocks of the Intensive Care Unit (ICU) of the Future: Intelligent ICU of the Future
An observational study of Pain and Delirium, run by University of Florida at 1 site in United States.
Trial summary
The objective of this project is to create deep learning and machine learning models capable of recognizing patient visual cues, including facial expressions such as pain and functional activity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Video Monitoring, Accelerometer Monitoring and Electromyographic Monitoring
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2016to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults in the ICU or Adults visiting recruited patients in the ICU
Who may be able to join
- patient admitted to University of Florida (UF) Health Gainesville ICU
- Individual has their name designated on a patient's informed consent form giving them permission to view and modify facial and activity data collected about that patient
Who cannot join
- Anticipated ICU stay is less than one day
- Patient is on any form of contact precaution or isolation
- Patient is unable to wear a Shimmer3 unit
- ICU Patient Friends/Family:
- Age < 18
- They are unable to answer short questions on a touch screen display
- They are unable to wear a proximity sensor
- They were not on the listed of designated individuals specified in their friend/family members informed consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Hospital
Gainesville, Florida, 32608
About this study
Official title: Intelligent ICU of the Future Subtitles: *Autonomous Pain Recognition in Non-Verbal and Critically Ill Patients *Fundamental Intelligent Building Blocks of the Intensive Care Unit (ICU) of the Future *Intelligent Intensive Care Unit (I2CU): Pervasive Sensing and Artificial Intelligence for Augmented Clinical Decision-making *ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention
The objective of this project is to create deep learning and machine learning models capable of recognizing patient visual cues, including facial expressions such as pain and functional activity. Many important details related to the visual assessment of patients, such as facial expressions like pain, 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, and impending clinical deterioration, often cannot be incorporated into clinical status. The study team will develop a sensing system to recognize facial and body movements as patient visual cues. As part of a secondary evaluation method the study team will assess the models ability to detect delirium.
Read the detailed description
Pain is a critical national health problem with nearly 50% of critical care patients experience significant pain in the Intensive Care Unit (ICU). The under-assessment of pain response is one of the primary barriers to the adequate treatment of pain in critically ill patients, associated with many negative outcomes such as chronic pain after discharge, prolonged mechanical ventilation, longer ICU stay, and increased mortality risk. Nonetheless, many ICU patients are unable to self-report pain intensity due to clinical conditions, ventilation devices, and altered consciousness. Currently, behavioral pain scales are used to assess pain in nonverbal patients. Unfortunately, these scales require repetitive manual administration by overburdened nurses. Moreover, prior work suggests that nurses caring for quasi-sedated patients in critical care settings have considerable variability in pain intensity ratings. Furthermore, manual pain assessment tools lack the capability to monitor pain continuously and autonomously. Together, these challenges point to a critical need for developing objective and autonomous pain recognition systems.
Delirium is another common complication of hospitalization that poses significant health problems in hospitalized patients. It is most prevalent in surgical ICU patients with diagnosis rates up to 80%. It is characterized by changes in cognition, activity level, consciousness, and alertness. Delirium typically leads to changes in activity level and alertness that pose additional health risks including risk of fall, inadequate mobilization, disturbed sleep, inadequate pain control, and negative emotions. All of these effects are difficult to monitor in real-time and further contribute to worsening of patient's cognitive abilities, inhibit recovery, and slow down the rehabilitation process. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. Current Delirium assessments need to be performed by trained healthcare staff, are time consuming, and resource intensive. Due to the resources necessary to complete the assessment, delirium is often assessed twice per day, despite the transient nature of the disease state which can come and go undetected between the assessments. Jointly these obstacles demonstrate a dire need for real-time autonomous delirium detection.
The investigators hypothesize that the proposed model would be able to leverage accelerometer, electromyographic, and video data for the purpose of autonomously quantifying patient facial expressions such as pain, characterizing functional activities, and delirium status. Rationalizing that autonomous visual cue quantification and delirium detection can reduce nurse workload and can enable real-time pain and delirium monitoring. Early detection of delirium offers patients the best chance for good delirium treatment outcomes.
- Being tested
- Video Monitoring, Accelerometer Monitoring, Electromyographic Monitoring, Noise Level Monitoring, Light Level Monitoring
- Medical subject headings
- Pain, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video MonitoringOther
Patients may have video monitoring for up to seven days while in the ICU. The video system will be placed in an unobtrusive area in the patient's ICU room.
Accelerometer MonitoringOther
Patients may have accelerometer monitoring for up to seven days while in the ICU. Commercially available accelerometer units, which have been validated in previous clinical studies, will be used.
Electromyographic MonitoringOther
Also called EMG monitoring
Patients may have electromyographic monitoring for up to seven days while in the ICU.
Noise Level MonitoringOther
Patients may have noise level monitoring (in decibels) for up to seven days while in the ICU.
Light Level MonitoringOther
Patients may have light level monitoring for up to seven days while in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | Adults in admitted to an ICU at University of Florida Health Gainesville with an expected length of stay greater than 24 hours which are not on any form of contact precaution or isolation. Patients will have continuous video, accelerometer, and electromyographic monitoring for up to seven days while in the ICU. Receives: Other: Video Monitoring; Other: Accelerometer Monitoring; Other: Electromyographic Monitoring; Other: Noise Level Monitoring; Other: Light Level Monitoring | |
| ICU Patient Friends/Family Members | Adult visitors of participating ICU patients that are willing to provide feedback to the learning algorithms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defense Veterans Pain Reporting Scale (DVPRS)
Before discharge, patients will be shown three short video clips from their ICU admission and asked to rate their pain levels using the Defense Veterans Pain Reporting Scale. DVPRS is a 10 point visual scale used to self report pain (0-4 being mild pain; 5-7 being moderate pain; 8-10 being severe pain).
Measured: Before hospital discharge, up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start3 Feb 2016
- Primary completion18 Jan 2022
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), U.S. National Science Foundation, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905668
- Sponsor's protocol ID
- IRB201900354 -N
- Other IDs
- 1R21EB027344-01, 1750192, OCR20330, R01NS120924-01
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent ICU of the Future Subtitles: *Autonomous Pain Recognition in Non-Verbal and Critically Ill Patients *Fundamental Intelligent Building Blocks of the Intensive Care Unit (ICU) of the Future *Intelligent Intensive Care Unit (I2CU): Pervasive Sensing and Artificial Intelligence for Augmented Clinical Decision-making *ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention
- ClinicalTrials.gov ID
- NCT03905668
- Acronym / sponsor ID
- IRB201900354 -N
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), U.S. National Science Foundation, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to create deep learning and machine learning models capable of recognizing patient visual cues, including facial expressions such as pain and functional activity. Many important details related to the visual assessment of patients, such as facial expressions like pain, 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, and impending clinical deterioration, often cannot be incorporated into clinical status. The study team will develop a sensing system to recognize facial and body movements as patient visual cues. As part of a secondary evaluation method the study team will assess the models ability to detect delirium.
Detailed description
Pain is a critical national health problem with nearly 50% of critical care patients experience significant pain in the Intensive Care Unit (ICU). The under-assessment of pain response is one of the primary barriers to the adequate treatment of pain in critically ill patients, associated with many negative outcomes such as chronic pain after discharge, prolonged mechanical ventilation, longer ICU stay, and increased mortality risk. Nonetheless, many ICU patients are unable to self-report pain intensity due to clinical conditions, ventilation devices, and altered consciousness. Currently, behavioral pain scales are used to assess pain in nonverbal patients. Unfortunately, these scales require repetitive manual administration by overburdened nurses. Moreover, prior work suggests that nurses caring for quasi-sedated patients in critical care settings have considerable variability in pain intensity ratings. Furthermore, manual pain assessment tools lack the capability to monitor pain continuously and autonomously. Together, these challenges point to a critical need for developing objective and autonomous pain recognition systems.
Delirium is another common complication of hospitalization that poses significant health problems in hospitalized patients. It is most prevalent in surgical ICU patients with diagnosis rates up to 80%. It is characterized by changes in cognition, activity level, consciousness, and alertness. Delirium typically leads to changes in activity level and alertness that pose additional health risks including risk of fall, inadequate mobilization, disturbed sleep, inadequate pain control, and negative emotions. All of these effects are difficult to monitor in real-time and further contribute to worsening of patient's cognitive abilities, inhibit recovery, and slow down the rehabilitation process. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. Current Delirium assessments need to be performed by trained healthcare staff, are time consuming, and resource intensive. Due to the resources necessary to complete the assessment, delirium is often assessed twice per day, despite the transient nature of the disease state which can come and go undetected between the assessments. Jointly these obstacles demonstrate a dire need for real-time autonomous delirium detection.
The investigators hypothesize that the proposed model would be able to leverage accelerometer, electromyographic, and video data for the purpose of autonomously quantifying patient facial expressions such as pain, characterizing functional activities, and delirium status. Rationalizing that autonomous visual cue quantification and delirium detection can reduce nurse workload and can enable real-time pain and delirium monitoring. Early detection of delirium offers patients the best chance for good delirium treatment outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | – | Other: Video Monitoring, Other: Accelerometer Monitoring, Other: Electromyographic Monitoring, Other: Noise Level Monitoring, Other: Light Level MonitoringAdults in admitted to an ICU at University of Florida Health Gainesville with an expected length of stay greater than 24 hours which are not on any form of contact precaution or isolation. Patients will have continuous video, accelerometer, and electromyographic monitoring for up to seven days while in the ICU. |
| ICU Patient Friends/Family Members | – | –Adult visitors of participating ICU patients that are willing to provide feedback to the learning algorithms. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults in the ICU or Adults visiting recruited patients in the ICU
Key inclusion criteria (2 listed)
- patient admitted to University of Florida (UF) Health Gainesville ICU
- Individual has their name designated on a patient's informed consent form giving them permission to view and modify facial and activity data collected about that patient
Key exclusion criteria (8 listed)
- Anticipated ICU stay is less than one day
- Patient is on any form of contact precaution or isolation
- Patient is unable to wear a Shimmer3 unit
- Age < 18
- They are unable to answer short questions on a touch screen display
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video MonitoringPatients may have video monitoring for up to seven days while in the ICU. The video system will be placed in an unobtrusive area in the patient's ICU room. | Other | ICU Patients |
| Accelerometer MonitoringPatients may have accelerometer monitoring for up to seven days while in the ICU. Commercially available accelerometer units, which have been validated in previous clinical studies, will be used. | Other | ICU Patients |
| Electromyographic MonitoringAlso: EMG monitoringPatients may have electromyographic monitoring for up to seven days while in the ICU. | Other | ICU Patients |
| Noise Level MonitoringPatients may have noise level monitoring (in decibels) for up to seven days while in the ICU. | Other | ICU Patients |
| Light Level MonitoringPatients may have light level monitoring for up to seven days while in the ICU. | Other | ICU Patients |
Primary outcome
Defense Veterans Pain Reporting Scale (DVPRS)
Time frame: Before hospital discharge, up to Day 8
Before discharge, patients will be shown three short video clips from their ICU admission and asked to rate their pain levels using the Defense Veterans Pain Reporting Scale. DVPRS is a 10 point visual scale used to self report pain (0-4 being mild pain; 5-7 being moderate pain; 8-10 being severe pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Delirium, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defense Veterans Pain Reporting Scale (DVPRS) (time frame: Before hospital discharge, up to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.