Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
MLP-based Clinical Decision Support System (MLP-CDSS)
DeviceAn 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
BehavioralA 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
BehavioralA 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.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) groupExperimental treatment 3 interventions
Group B: routine care control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From ICU admission to ICU discharge or maximum 28 days, assessed per shift2
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
Time frame
Through Day 28 after ICU admission.Secondary outcomes
1
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.
Time frame
Daily from enrollment until ICU discharge or up to a maximum of 28 days.2
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.
Time frame
Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.3
ICU Mortality
The number of participants who died during their stay in the Intensive Care Unit.
Time frame
From ICU admission to ICU discharge (estimated up to 28 days)4
90-day All-cause Mortality
The number of participants who died from any cause within 90 days following discharge from the hospital.
Time frame
90 days after hospital discharge.Sponsors and contacts
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Source ClinicalTrials.gov
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