Precision ICU Care: Evaluating an AI-Driven Nursing Decision Support System for Delirium Prevention
2026年6月1日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
188
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hsiao-Yean Chiu, Professor
- 電話番号：6329 886-2-27361661
- メール：hychiu0315@tmu.edu.tw
研究場所
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Taipei、台湾、110
- Taipei Medical University, Taipei, 110
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コンタクト：
- Hisao-Yean Chiu, Professor
- 電話番号：6329 886-2-27361661
- メール：hychiu0315@tmu.edu.tw
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：routine care control group
The control group will receive routine care, including delirium assessments and sleep environment management.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of ICU delirium
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Subjective Sleep Quality
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年1月1日
研究の完了 (推定)
2028年6月1日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。