このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Predicting Extubation Failure Using Machine Learning

2026年10月31日 更新者:Adhrie Sugiarto、Universitas Indonesia

Prediction of Extubation Failure in Mechanically Ventilated Adult Patients Using a Machine Learning-Based Approach

The goal of this observational study is to predict who will have problems after the breathing tube is removed. Taking out the tube is called extubation, and having these problems is called extubation failure. Participants are adults in the intensive care unit (ICU) who use a breathing machine (ventilator).

The main questions it aims to answer are:

  • How well can computer tools predict problems in the 7 days after the tube is removed?
  • Which information, such as age or blood tests, matters most for the prediction?

Extubation failure means the participant needs the tube put back in, needs a surgical opening in the neck to help breathing, or dies.

Researchers will use machine learning to build the computer tools. Machine learning is a type of artificial intelligence that finds patterns in data. Researchers will compare five types of machine learning to see which works best. They will build the tools with participants from Dr. Cipto Mangunkusumo National General Hospital in Jakarta. They will test the tools with participants from Universitas Indonesia Hospital in Depok.

Participants get their usual care. Doctors do not use the tools to make treatment decisions. Researchers will:

  • Record health information about participants before the tube is removed
  • Follow participants for 7 days after the tube is removed

調査の概要

状態

募集

詳細な説明

This is a prospective, multicenter, observational cohort study. Extubation and reintubation decisions are made by the attending anesthesiologists as part of routine care and are not informed by the models. The models will be developed only after data collection is complete.

Data collection:

Candidate predictors are chosen from previous studies and clinical relevance. They fall into four groups: patient characteristics, clinical condition, mechanical ventilation parameters, and laboratory results. Trained ICU staff and research assistants record them from bedside monitors, ventilator displays, paper and electronic medical records, and family interviews. Patient characteristics and severity scores (APACHE II and SAPS II) are recorded at ICU admission. Before extubation, ventilator parameters are taken within 4 hours, clinical condition within 24 hours, and laboratory results within 48 hours, using the measurement closest to extubation. Patients are followed for 7 days after planned extubation through bedside monitoring and review of medical records after transfer to the ward.

Participants:

Participants are enrolled when they receive invasive mechanical ventilation in the ICU, before it is known whether they will have a planned extubation. After enrollment, participants are excluded from the analysis if they die or have a tracheostomy without the breathing tube being removed; stay on a breathing machine for more than 2 weeks without the tube being removed; have an unplanned extubation (the tube was pulled out by the participant or by accident); are transferred to another hospital before extubation or within 7 days after; or if they or their family decline further intensive care. The number of participants enrolled is therefore larger than the number analyzed. The number analyzed will be reported in the results article.

Data management:

Data are entered into REDCap, a secure web-based data management application, using study codes without names, medical record numbers, or dates of birth. Data are stored at the Big Data Center, Indonesia Medical Education and Research Institute (IMERI), Universitas Indonesia. Research assistants periodically check the data for completeness and implausible values. Values that are not measured are left blank during data collection and will be handled in the analysis.

Sample size:

The development cohort target was calculated to estimate sensitivity (80%, precision of 10 percentage points, 95% confidence), assuming a 10% extubation failure rate and 10% dropout. The external validation target was calculated to estimate the extubation failure rate with a 5 percentage point margin of error. The development sample is smaller than formal prediction model sample size criteria would require. The study is therefore exploratory, and the external validation is preliminary.

Planned analysis:

Five supervised machine learning algorithms will be developed: LightGBM, CatBoost, XGBoost, random forest, and support vector machine. The development cohort will be randomly split, stratified by outcome, into training, validation, and holdout test sets. Missing values will be imputed, and class imbalance will be handled during model training. The classification threshold will be chosen on the validation set. Performance will be assessed on the holdout test set and on the external validation cohort, using the final models without modification. Predictor importance will be assessed with SHAP values for tree-based models and permutation importance for the support vector machine.

Reporting:

This study follows the TRIPOD+AI reporting guideline (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, updated for artificial intelligence).

研究の種類

観察的

入学 (推定)

1065

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:Adhrie Sugiarto
  • 電話番号:+62213157008
  • メール:adhrie@gmail.com

研究連絡先のバックアップ

研究場所

    • DKI Jakarta
      • Jakarta、DKI Jakarta、インドネシア、10430
        • 募集
        • Cipto Mangunkusumo National General Hospital (RSCM)
        • コンタクト:
        • 主任研究者:
          • Adhrie Sugiarto, MD, SpAn-KIC
    • West Java
      • Depok、West Java、インドネシア、16424
        • 完了
        • Universitas Indonesia Hospital (RS UI)

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Adults treated in the intensive care units (ICUs) of two tertiary referral hospitals in Indonesia: Dr. Cipto Mangunkusumo National General Hospital in Jakarta (development cohort) and Universitas Indonesia Hospital in Depok (external validation cohort).

説明

Inclusion Criteria:

  • Aged 18 years or older
  • Receiving invasive mechanical ventilation through a breathing tube in the windpipe (endotracheal tube) in the intensive care unit (ICU)

Exclusion Criteria:

- Used a breathing machine through a tracheostomy (a surgical opening in the neck) when admitted to the ICU

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

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
Development Cohort (RSCM)

Adult ICU patients (≥18 years) on invasive mechanical ventilation via endotracheal tube at Dr. Cipto Mangunkusumo National General Hospital (RSCM), Jakarta, who underwent planned extubation. Enrolled between Sept 2024-Sept 2026. Pre-extubation predictors (patient characteristics, clinical condition, ventilator parameters, laboratory results) are recorded prospectively. Outcome: extubation failure, defined as reintubation, tracheostomy, or death from any cause within 7 days after planned extubation. Data are used to develop and internally validate machine learning models (LightGBM, CatBoost, XGBoost, random forest, SVM). No intervention is assigned; extubation follows routine care.

External Validation Cohort (RS UI)

Adult ICU patients (≥18 years) on invasive mechanical ventilation via endotracheal tube at Universitas Indonesia Hospital (RS UI) who underwent planned extubation, using the same eligibility criteria, predictors, and 7-day outcome definition as the development cohort. Recruited during a period overlapping with the development cohort (Feb 2025-Sept 2026). Data are used only to externally validate the final models developed in the RSCM cohort, without modification. No intervention is assigned; extubation follows routine care.

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
Area under the receiver operating characteristic curve (AUROC) of machine learning models for predicting extubation failure
時間枠:up to 7 days after planned extubation

Discrimination of five supervised machine learning models (LightGBM, CatBoost, XGBoost, random forest, SVM) for predicting extubation failure in adult ICU patients on mechanical ventilation, including the difference in AUROC among the five algorithms. Extubation failure is defined as reintubation, tracheostomy, or death from any cause within 7 days after planned extubation. AUROC (unitless, range 0-1) is reported with 95% CI in the internal testing set (RSCM) and the external validation cohort (RS UI).

up to 7 days after planned extubation

二次結果の測定

結果測定
メジャーの説明
時間枠
Accuracy of machine learning models for predicting extubation failure
時間枠:up to 7 days after planned extubation

Proportion of patients correctly classified (true positives plus true negatives, divided by all patients) by each of the five machine learning models for predicting extubation failure, at a probability threshold determined in the validation set by maximizing the F1-score. Reported as a percentage with 95% CI in the internal testing set and the external validation cohort.

up to 7 days after planned extubation
Sensitivity (recall) of machine learning models for predicting extubation failure
時間枠:up to 7 days after planned extubation

Proportion of patients with extubation failure who are correctly identified (true positives divided by true positives plus false negatives) by each of the five machine learning models, at a probability threshold determined in the validation set by maximizing the F1-score. Reported as a percentage with 95% CI in the internal testing set and the external validation cohort.

up to 7 days after planned extubation
Positive predictive value (precision) of machine learning models for predicting extubation failure
時間枠:up to 7 days after planned extubation

Proportion of patients predicted to have extubation failure who actually have extubation failure (true positives divided by true positives plus false positives) for each of the five machine learning models, at a probability threshold determined in the validation set by maximizing the F1-score. Reported as a percentage with 95% CI in the internal testing set and the external validation cohort.

up to 7 days after planned extubation
Mean absolute SHAP value of candidate predictors for extubation failure (tree-based models)
時間枠:up to 7 days after planned extubation

Contribution of candidate predictors measured before extubation (patient characteristics, clinical condition, mechanical ventilation parameters, and laboratory results) to the predictions of each tree-based model (LightGBM, CatBoost, XGBoost, random forest), expressed as mean absolute SHAP value on the predicted probability scale (unitless, range 0-1).

up to 7 days after planned extubation
Permutation importance of candidate predictors for extubation failure (SVM model)
時間枠:up to 7 days after planned extubation

Contribution of candidate predictors measured before extubation to the predictions of the support vector machine model, expressed as the mean decrease in AUROC (unitless) when the values of each predictor are randomly permuted in the internal testing set.

up to 7 days after planned extubation

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。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (実際)

2024年9月4日

一次修了 (推定)

2027年1月23日

研究の完了 (推定)

2027年1月31日

試験登録日

最初に提出

2026年10月18日

QC基準を満たした最初の提出物

2026年10月31日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年10月31日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する