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

1 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

188

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Hsiao-Yean Chiu, Professor
  • Número de teléfono: 6329 886-2-27361661
  • Correo electrónico: hychiu0315@tmu.edu.tw

Ubicaciones de estudio

  • Taiwán
      • Taipei, Taiwán, 110
        • Taipei Medical University, Taipei, 110
        • Contacto:
          • Hisao-Yean Chiu, Professor
          • Número de teléfono: 6329 886-2-27361661
          • Correo electrónico: hychiu0315@tmu.edu.tw

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Conductual: 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.
Sin intervención: routine care control group
The control group will receive routine care, including delirium assessments and sleep environment management.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of ICU delirium
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Subjective Sleep Quality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Taipei Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de enero de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • N202502041

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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