Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence
This project plans to employ a multi-center retrospective and prospective cohort study design. It aims to collect data on ventilator support strategies, duration of invasive mechanical ventilation, incidence of ventilator dependence, high-risk factors for ventilator dependence, and in-hospital mortality rates among different chronic disease populations in the ICU. This will involve combining unstructured data with real-time bedside multi-dimensional high-frequency data (including dynamic changes in data volume, respiratory mechanics, diaphragm ultrasound, EIT, diaphragm electrical activity, and other monitoring parameters) to construct digital phenotypes for chronic disease patients with ventilator dependence and identify high-risk factors for ventilator dependence in this population.
Specifically, the research will:
Utilize an integrated modular intelligent respiratory monitoring system, previously developed by the project team, to achieve dynamic monitoring of multi-dimensional indicators.
Systematically collect dynamic clinical characteristics of mechanical ventilation dependence in chronic disease populations through retrospective and prospective cohort studies, and employ multivariate statistical analysis, machine learning, and other techniques to identify no fewer than 5-6 high-risk factors for ventilator dependence in chronic disease patients.
Establish a data ecosystem suitable for chronic disease patients undergoing mechanical ventilation, build a multi-dimensional high-frequency data platform for chronic ventilator-dependent populations, map the full cycle from intubation to mechanical ventilation support, weaning, and extubation, and construct multidimensional digital phenotypes for high-risk chronic disease patients with ventilator dependence.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age > 18 years old.
- Patients admitted to ICU and receiving invasive mechanical ventilation.
- Comorbid with chronic diseases.
Exclusion Criteria:
- Total invasive mechanical ventilation duration ≤ 48 hours.
- Death within 7 days after ICU admission.
- Withdrawal of treatment.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Patients in the Multicenter Retrospective Cohort
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Patients in the Multi-Center Prospective Cohort
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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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Proportion of ventilator dependence（mechanical ventilation time≥7 days） in chronic disease patients receiving invasive mechanical ventilation
時間枠：From enrollment to 7 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.
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From enrollment to 7 days
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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 |
|---|---|---|
|
Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
時間枠：21 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 14 and 21 days of the initial intubation.
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21 days
|
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Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Time to first extubation in chronic disease patients
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Proportion of first extubation failure in chronic disease patients
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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High-risk factors for first extubation failure in chronic disease patients
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
|
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ICU mortality rate
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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In-hospital mortality rate
時間枠：during hospitalization，assessed up to 28 days
|
during hospitalization，assessed up to 28 days
|
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ICU length of stay
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
|
|
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Total hospital length of stay
時間枠：during hospitalization，assessed up to 28 days
|
during hospitalization，assessed up to 28 days
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Duration of invasive mechanical ventilation
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
|
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Incidence of Ventilator-Associated Pneumonia (VAP)
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Proportion of patients undergoing tracheostomy
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Time of tracheostomy
時間枠：during hospitalization，assessed up to 28 days
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among those who receive tracheostomy
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during hospitalization，assessed up to 28 days
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High-risk factors for ventilator dependence in chronic disease patients
時間枠：during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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協力者と研究者
協力者
捜査官
- 主任研究者：Xu Huang, MD、Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-KY-099
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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