- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07631494
Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Hsiao-Yean Chiu, Professor
- Puhelinnumero: 6329 886-2-27361661
- Sähköposti: hychiu0315@tmu.edu.tw
Opiskelupaikat
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Taipei, Taiwan, 110
- Taipei Medical University, Taipei, 110
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Ottaa yhteyttä:
- Hisao-Yean Chiu, Professor
- Puhelinnumero: 6329 886-2-27361661
- Sähköposti: hychiu0315@tmu.edu.tw
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
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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.
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.
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.
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Ei väliintuloa: routine care control group
The control group will receive routine care, including delirium assessments and sleep environment management.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Incidence of ICU delirium
Aikaikkuna: From ICU admission to ICU discharge or maximum 28 days, assessed per shift
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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.
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From ICU admission to ICU discharge or maximum 28 days, assessed per shift
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Delirium-Free Days
Aikaikkuna: Through Day 28 after ICU admission.
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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
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Through Day 28 after ICU admission.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Subjective Sleep Quality
Aikaikkuna: Daily from enrollment until ICU discharge or up to a maximum of 28 days.
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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:
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Daily from enrollment until ICU discharge or up to a maximum of 28 days.
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Objective Sleep Quality
Aikaikkuna: Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
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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.
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Continuous monitoring every night from enrollment until ICU discharge or up to a maximum of 28 days.
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ICU Mortality
Aikaikkuna: From ICU admission to ICU discharge (estimated up to 28 days)
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The number of participants who died during their stay in the Intensive Care Unit.
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From ICU admission to ICU discharge (estimated up to 28 days)
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90-day All-cause Mortality
Aikaikkuna: 90 days after hospital discharge.
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The number of participants who died from any cause within 90 days following discharge from the hospital.
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90 days after hospital discharge.
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Cumulative Dose of Sedatives and Analgesics
Aikaikkuna: Daily during the ICU stay, up to 28 days.
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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).
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Daily during the ICU stay, up to 28 days.
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Hospital Length of Stay (LOS)
Aikaikkuna: From study enrollment to hospital discharge (expected up to 3 month).
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The total number of days from study enrollment to hospital discharge or death.
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From study enrollment to hospital discharge (expected up to 3 month).
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ICU-related Adverse Events
Aikaikkuna: Throughout the ICU stay, up to 28 days
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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).
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Throughout the ICU stay, up to 28 days
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ICU Length of Stay (ICU LOS)
Aikaikkuna: From ICU admission to ICU discharge (estimated up to 28 days).
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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.
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From ICU admission to ICU discharge (estimated up to 28 days).
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Health-Related Quality of Life
Aikaikkuna: At 3 months and 6 months after hospital discharge.
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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.
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At 3 months and 6 months after hospital discharge.
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Duration of Mechanical Ventilation
Aikaikkuna: Throughout the ICU stay, from enrollment up to a maximum of 28 days.
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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.
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Throughout the ICU stay, from enrollment up to a maximum of 28 days.
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Long-term Cognitive Function
Aikaikkuna: At 3 months and 6 months after hospital discharge.
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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.
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
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