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NCT Number: NCT07631494

Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention

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.

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Key information

Conditions

Delirium in the Intensive Care Unit Confusion Delirium Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 Intervention

Behavioral

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 Exercise

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Subjective Sleep Quality

    Time frame: Daily from enrollment until ICU discharge or up to a maximum of 28 days.

    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.

  2. Objective Sleep Quality

    Time frame: Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.

    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.

  3. ICU Mortality

    Time frame: From ICU admission to ICU discharge (estimated up to 28 days)

    The number of participants who died during their stay in the Intensive Care Unit.

  4. 90-day All-cause Mortality

    Time frame: 90 days after hospital discharge.

    The number of participants who died from any cause within 90 days following discharge from the hospital.

  5. Cumulative Dose of Sedatives and Analgesics

    Time frame: Daily during the ICU stay, up to 28 days.

    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).

  6. Hospital Length of Stay (LOS)

    Time frame: From study enrollment to hospital discharge (expected up to 3 month).

    The total number of days from study enrollment to hospital discharge or death.

  7. ICU-related Adverse Events

    Time frame: Throughout the ICU stay, up to 28 days

    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).

  8. ICU Length of Stay (ICU LOS)

    Time frame: From ICU admission to ICU discharge (estimated up to 28 days).

    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.

  9. Health-Related Quality of Life

    Time frame: At 3 months and 6 months after hospital discharge.

    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.

  10. Duration of Mechanical Ventilation

    Time frame: Throughout the ICU stay, from enrollment up to a maximum of 28 days.

    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.

  11. Long-term Cognitive Function

    Time frame: At 3 months and 6 months after hospital discharge.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiao-Yean Chiu, Professor

CONTACT

[email protected]

886-2-27361661 ext. 6329

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Efficacy of an Intelligent Computational Nursing Decision Support System in Precision Critical Care for Delirium Prevention: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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