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

1 giugno 2026 aggiornato da: Hsiao-Yean Chiu, Taipei Medical University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

188

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University, Taipei, 110
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Smart Computing Assisted Nursing Decision in Delirium Prevention(SCAN-D) group
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.
Dispositivo: 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.
Comportamentale: VR-based Cognitive Intervention
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.
Comportamentale: VR-assisted Early Mobility Exercise
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.
Nessun intervento: routine care control group
The control group will receive routine care, including delirium assessments and sleep environment management.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of ICU delirium
Lasso di tempo: 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.
From ICU admission to ICU discharge or maximum 28 days, assessed per shift
Delirium-Free Days
Lasso di tempo: 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
Through Day 28 after ICU admission.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subjective Sleep Quality
Lasso di tempo: 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.
Daily from enrollment until ICU discharge or up to a maximum of 28 days.
Objective Sleep Quality
Lasso di tempo: 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.
Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
ICU Mortality
Lasso di tempo: 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.
From ICU admission to ICU discharge (estimated up to 28 days)
90-day All-cause Mortality
Lasso di tempo: 90 days after hospital discharge.
The number of participants who died from any cause within 90 days following discharge from the hospital.
90 days after hospital discharge.
Cumulative Dose of Sedatives and Analgesics
Lasso di tempo: 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).
Daily during the ICU stay, up to 28 days.
Hospital Length of Stay (LOS)
Lasso di tempo: From study enrollment to hospital discharge (expected up to 3 month).
The total number of days from study enrollment to hospital discharge or death.
From study enrollment to hospital discharge (expected up to 3 month).
ICU-related Adverse Events
Lasso di tempo: 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).
Throughout the ICU stay, up to 28 days
ICU Length of Stay (ICU LOS)
Lasso di tempo: 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.
From ICU admission to ICU discharge (estimated up to 28 days).
Health-Related Quality of Life
Lasso di tempo: 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.
At 3 months and 6 months after hospital discharge.
Duration of Mechanical Ventilation
Lasso di tempo: 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.
Throughout the ICU stay, from enrollment up to a maximum of 28 days.
Long-term Cognitive Function
Lasso di tempo: 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.
At 3 months and 6 months after hospital discharge.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • N202502041

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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