Delirium in the Intensive Care UnitNCT07631494
Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention
A study testing MLP-based Clinical Decision Support System (MLP-CDSS), VR-based Cognitive Intervention and VR-assisted Early Mobility Exercise in people with Delirium in the Intensive Care Unit and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Delirium affects up to 83% of mechanically ventilated patients in the Intensive Care Unit (ICU), often leading to longer hospital stays and long-term memory or cognitive problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium in the Intensive Care Unit, Sleep Quality
- What is being tested?
- MLP-based Clinical Decision Support System (MLP-CDSS), VR-based Cognitive Intervention and VR-assisted Early Mobility Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years
- High risk of developing delirium are defined as PRE-DELIRIC (PREdiction of DELIRium in ICu patients) with a score of ≥40%
- Sedation assessment form (Richmond Agitation-Sedation). Scale, RASS) is assessed as between +1 and -1
- Patient is clearly aware and able to communicate with Chinese and Taiwanese customers.
Who cannot join
- Those who have developed delirium before joining the study (assessed by the Intensive Care Delirium Screening Checklist (ICDSC) >4 points)
- Expected to stay in the ICU for less than 24 hours
- APACHE II score > 25 (meaning > 50% mortality)
- Delirium cannot be evaluated, such as those with severe acute brain injury, audio-visual impairment, speech problems, psychotic disorders, aphasia, or in the entire ICU During this period, patient remained comatose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University, Taipei, 110
Taipei, 110
Hisao-Yean Chiu, Professor, 886-2-27361661 ext. 6329, hychiu0315@tmu.edu.tw
About this study
Official title: Efficacy of an Intelligent Computational Nursing Decision Support System in Precision Critical Care for Delirium Prevention: A Randomized Controlled Trial
Delirium affects up to 83% of mechanically ventilated patients in the Intensive Care Unit (ICU), often leading to longer hospital stays and long-term memory or cognitive problems. While standard care protocols (such as the ABCDEF bundle) exist, they are often difficult to implement fully due to their complexity and the heavy workload on nursing staff.
To address these challenges, this study introduces a 'Precision Nursing' approach by integrating Artificial Intelligence (AI) and Virtual Reality (VR). We will implement an AI-driven system to assist nurses in making personalized care decisions more efficiently. Additionally, interactive VR technology will be used to stimulate patients' cognitive function and encourage early mobility. Our goal is to reduce the clinical burden on healthcare providers while significantly improving recovery outcomes for ICU patients.
Read the detailed description
Delirium affects up to 83% of ventilated ICU patients, necessitating precise non-pharmacological interventions like the SCAN-D program, which aims to improve outcomes by integrating smart computing and virtual reality into nursing decisions. This three-year, assessor-blinded, parallel randomized controlled trial will enroll 188 patients, assigning them to either usual care or the SCAN-D group, where the latter receives personalized strategies based on machine learning risk weights, including family-supervised immersive VR exercise and cognitive training. Throughout their stay, patients will be monitored via shift-based assessments (ICDSC/RASS) and nightly sleep tracking using actigraphy combined with one-lead EEG, while long-term cognitive function and quality of life (EQ-5D-3L) will be evaluated at three and six months post-discharge. The primary outcomes are the incidence of delirium and delirium-free days within the first 28 days of ICU admission, measured using the ICU Delirium Screening Checklist. Secondary outcomes include sleep quality and quantity, functional status during the ICU stay, ICU length of stay, duration of mechanical ventilation, total hospital length of stay, ICU mortality rate, Sedative and Analgesic Loading, 90-day Mortality Post-discharge, cognitive function, and quality of life. Finally, the collected data will be analyzed using SPSS 22.0 through independent t-tests, Chi-square tests, and Generalized Estimating Equations (GEE) to determine the program's efficacy in reducing delirium incidence and enhancing overall patient recovery.
- Conditions
- Delirium in the Intensive Care Unit, Sleep Quality
- Being tested
- MLP-based Clinical Decision Support System (MLP-CDSS), VR-based Cognitive Intervention, VR-assisted Early Mobility Exercise
- Keywords
- Artificial Intelligence, delirium, intensive care unit, Virtual Reality, sleep, machine learning
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLP-based Clinical Decision Support System (MLP-CDSS)Device
An AI-integrated system utilizing a Multilayer Perceptron (MLP) model to predict delirium risk and guide targeted interventions. The system continuously analyzes real-time data from Electronic Health Records (EHR), including physiological parameters, medication history, and laboratory results.
VR-based Cognitive InterventionBehavioural
A virtual reality intervention designed to provide cognitive stimulation and reduce sensory deprivation. Patients engage in interactive games (e.g., traditional-themed tasks such as goldfish scooping or lantern festivals) that require attention, memory, and spatial orientation. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week.
VR-assisted Early Mobility ExerciseBehavioural
A VR-based physical activity program focused on promoting upper limb movement and range of motion. The virtual environment encourages patients to perform specific gestures or reaching tasks while in bed or a seated position, aiming to improve mobility and reduce the physical deconditioning common in ICU stays. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group | Experimental | The algorithm will calculate variable weights and select features contributing to 80% of the risk. These variables will guide the implementation of personalized delirium prevention strategies, with making decision based on nurses' clinical expertise. Receives: Device: MLP-based Clinical Decision Support System (MLP-CDSS); Behavioral: VR-based Cognitive Intervention; Behavioral: VR-assisted Early Mobility Exercise |
| routine care control group | No intervention | The control group will receive routine care, including delirium assessments and sleep environment management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU delirium
The proportion of participants who develop delirium during their ICU stay. Delirium is assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The checklist evaluates 8 clinical signs, with each item scored 0 or 1. A total score of 4 or higher is defined as a "positive" delirium diagnosis.
Measured: From ICU admission to ICU discharge or maximum 28 days, assessed per shift
Delirium-Free Days
The number of days alive and free of delirium during ICU stay. Delirium status is assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC). A "delirium-free day" is defined as a calendar day on which the patient is alive and has an ICDSC score of less than 4
Measured: Through Day 28 after ICU admission.
Secondary outcomes (11)
Subjective Sleep Quality
Daily sleep quality as perceived by the participant, measured using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a 5-item visual analog scale that assesses:
- Sleep depth
- Sleep latency (falling asleep)
- Number of awakenings
- Time to return to sleep
- Overall sleep quality. Each item is scored from 0 to 100 mm. The total score is the average of the five items. The total score ranges from 0 to 100, where higher scores indicate better sleep quality.
Measured: Daily from enrollment until ICU discharge or up to a maximum of 28 days.
Objective Sleep Quality
Description: Objective sleep status will be evaluated by SOMNOwatch™, which can extract not only sleep related parameters but also calculate sleep stages using additional electroencephalography (EEG) sensors.
Measured: Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
ICU Mortality
The number of participants who died during their stay in the Intensive Care Unit.
Measured: From ICU admission to ICU discharge (estimated up to 28 days)
90-day All-cause Mortality
The number of participants who died from any cause within 90 days following discharge from the hospital.
Measured: 90 days after hospital discharge.
Cumulative Dose of Sedatives and Analgesics
The total cumulative dose of sedatives (e.g., Propofol, Midazolam) and analgesics (e.g., Fentanyl, Morphine) administered during the ICU stay. To allow comparison, doses will be converted to equivalents (e.g., Midazolam equivalents for sedatives and Morphine equivalents for analgesics).
Measured: Daily during the ICU stay, up to 28 days.
Hospital Length of Stay (LOS)
The total number of days from study enrollment to hospital discharge or death.
Measured: From study enrollment to hospital discharge (expected up to 3 month).
ICU-related Adverse Events
The frequency and type of adverse events occurring in the ICU, including but not limited to: unplanned extubation, falls, pressure ulcers, and ventilator-associated pneumonia (VAP).
Measured: Throughout the ICU stay, up to 28 days
ICU Length of Stay (ICU LOS)
The total number of days the participant remains in the Intensive Care Unit, calculated from the date of ICU admission to the date of ICU discharge or death.
Measured: From ICU admission to ICU discharge (estimated up to 28 days).
Health-Related Quality of Life
The Euro Qol Five-Dimensional Five-Level Scale (EQ-5D-5L) is used to evaluate health-related QoL. The health status classification comprises five dimensions, each with five levels, calculated using specific values. The vertical analog scale assesses the patient's overall evaluation of their current health status, ranging from 0 to 100. Higher scores indicate greater QoL.
Measured: At 3 months and 6 months after hospital discharge.
Duration of Mechanical Ventilation
The total number of days during which the participant requires mechanical ventilation support while in the Intensive Care Unit. This includes both invasive (via endotracheal tube or tracheostomy) and non-invasive ventilation (NIV). The duration is calculated from the initiation of mechanical ventilation to successful weaning and extubation.
Measured: Throughout the ICU stay, from enrollment up to a maximum of 28 days.
Long-term Cognitive Function
Cognitive performance assessed via the Telephone Interview for Cognitive Status (TICS). The TICS is an 11-item screening instrument specifically designed for telephone administration to patients who cannot be assessed in person.
The total score ranges from 0 to 41, where higher scores indicate better cognitive performance.
Measured: At 3 months and 6 months after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631494
- Sponsor's protocol ID
- N202502041
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intelligent Computational Nursing Decision Support System in Precision Critical Care for Delirium Prevention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07631494
- Acronym / sponsor ID
- N202502041
- Conditions
- Delirium in the Intensive Care Unit, Sleep Quality
- Keywords
- Artificial Intelligence, delirium, intensive care unit, Virtual Reality, sleep, machine learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Delirium affects up to 83% of mechanically ventilated patients in the Intensive Care Unit (ICU), often leading to longer hospital stays and long-term memory or cognitive problems. While standard care protocols (such as the ABCDEF bundle) exist, they are often difficult to implement fully due to their complexity and the heavy workload on nursing staff.
To address these challenges, this study introduces a 'Precision Nursing' approach by integrating Artificial Intelligence (AI) and Virtual Reality (VR). We will implement an AI-driven system to assist nurses in making personalized care decisions more efficiently. Additionally, interactive VR technology will be used to stimulate patients' cognitive function and encourage early mobility. Our goal is to reduce the clinical burden on healthcare providers while significantly improving recovery outcomes for ICU patients.
Detailed description
Delirium affects up to 83% of ventilated ICU patients, necessitating precise non-pharmacological interventions like the SCAN-D program, which aims to improve outcomes by integrating smart computing and virtual reality into nursing decisions. This three-year, assessor-blinded, parallel randomized controlled trial will enroll 188 patients, assigning them to either usual care or the SCAN-D group, where the latter receives personalized strategies based on machine learning risk weights, including family-supervised immersive VR exercise and cognitive training. Throughout their stay, patients will be monitored via shift-based assessments (ICDSC/RASS) and nightly sleep tracking using actigraphy combined with one-lead EEG, while long-term cognitive function and quality of life (EQ-5D-3L) will be evaluated at three and six months post-discharge. The primary outcomes are the incidence of delirium and delirium-free days within the first 28 days of ICU admission, measured using the ICU Delirium Screening Checklist. Secondary outcomes include sleep quality and quantity, functional status during the ICU stay, ICU length of stay, duration of mechanical ventilation, total hospital length of stay, ICU mortality rate, Sedative and Analgesic Loading, 90-day Mortality Post-discharge, cognitive function, and quality of life. Finally, the collected data will be analyzed using SPSS 22.0 through independent t-tests, Chi-square tests, and Generalized Estimating Equations (GEE) to determine the program's efficacy in reducing delirium incidence and enhancing overall patient recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group | Experimental | Device: MLP-based Clinical Decision Support System (MLP-CDSS), Behavioral: VR-based Cognitive Intervention, Behavioral: VR-assisted Early Mobility ExerciseThe algorithm will calculate variable weights and select features contributing to 80% of the risk. These variables will guide the implementation of personalized delirium prevention strategies, with making decision based on nurses' clinical expertise. |
| routine care control group | No intervention | –The control group will receive routine care, including delirium assessments and sleep environment management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years
- High risk of developing delirium are defined as PRE-DELIRIC (PREdiction of DELIRium in ICu patients) with a score of ≥40%
- Sedation assessment form (Richmond Agitation-Sedation). Scale, RASS) is assessed as between +1 and -1
- Patient is clearly aware and able to communicate with Chinese and Taiwanese customers.
Key exclusion criteria (4 listed)
- Those who have developed delirium before joining the study (assessed by the Intensive Care Delirium Screening Checklist (ICDSC) >4 points)
- Expected to stay in the ICU for less than 24 hours
- APACHE II score > 25 (meaning > 50% mortality)
- Delirium cannot be evaluated, such as those with severe acute brain injury, audio-visual impairment, speech problems, psychotic disorders, aphasia, or in the entire ICU During this period, patient remained comatose.
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 |
|---|---|---|
| MLP-based Clinical Decision Support System (MLP-CDSS)An AI-integrated system utilizing a Multilayer Perceptron (MLP) model to predict delirium risk and guide targeted interventions. The system continuously analyzes real-time data from Electronic Health Records (EHR), including physiological parameters, medication history, and laboratory results. | Device | Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group |
| VR-based Cognitive InterventionA virtual reality intervention designed to provide cognitive stimulation and reduce sensory deprivation. Patients engage in interactive games (e.g., traditional-themed tasks such as goldfish scooping or lantern festivals) that require attention, memory, and spatial orientation. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week. | Behavioural | Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group |
| VR-assisted Early Mobility ExerciseA VR-based physical activity program focused on promoting upper limb movement and range of motion. The virtual environment encourages patients to perform specific gestures or reaching tasks while in bed or a seated position, aiming to improve mobility and reduce the physical deconditioning common in ICU stays. These sessions are conducted twice daily for total 30-40 minutes, 3-4 times a week. | Behavioural | Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group |
Primary outcome
Incidence of ICU delirium
Time frame: From ICU admission to ICU discharge or maximum 28 days, assessed per shift
The proportion of participants who develop delirium during their ICU stay. Delirium is assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The checklist evaluates 8 clinical signs, with each item scored 0 or 1. A total score of 4 or higher is defined as a "positive" delirium diagnosis.
Delirium-Free Days
Time frame: Through Day 28 after ICU admission.
The number of days alive and free of delirium during ICU stay. Delirium status is assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC). A "delirium-free day" is defined as a calendar day on which the patient is alive and has an ICDSC score of less than 4
11 secondary outcomes
Subjective Sleep Quality
Time frame: Daily from enrollment until ICU discharge or up to a maximum of 28 days.
Objective Sleep Quality
Time frame: Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
ICU Mortality
Time frame: From ICU admission to ICU discharge (estimated up to 28 days)
90-day All-cause Mortality
Time frame: 90 days after hospital discharge.
Cumulative Dose of Sedatives and Analgesics
Time frame: Daily during the ICU stay, up to 28 days.
Hospital Length of Stay (LOS)
Time frame: From study enrollment to hospital discharge (expected up to 3 month).
ICU-related Adverse Events
Time frame: Throughout the ICU stay, up to 28 days
ICU Length of Stay (ICU LOS)
Time frame: From ICU admission to ICU discharge (estimated up to 28 days).
Health-Related Quality of Life
Time frame: At 3 months and 6 months after hospital discharge.
Duration of Mechanical Ventilation
Time frame: Throughout the ICU stay, from enrollment up to a maximum of 28 days.
Long-term Cognitive Function
Time frame: At 3 months and 6 months after hospital discharge.
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 8 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MLP-based Clinical Decision Support System (MLP-CDSS), VR-based Cognitive Intervention and VR-assisted Early Mobility Exercise in people with Delirium in the Intensive Care Unit and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jun 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 Taiwan. 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?
Contact Hsiao-Yean Chiu, Professor (886-2-27361661 ext. 6329, hychiu0315@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU delirium (time frame: From ICU admission to ICU discharge or maximum 28 days, assessed per shift). The study lists 2 primary outcomes in all. 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 8 Jun 2026.