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Predicting Extubation Failure Using Machine Learning

31 października 2026 zaktualizowane przez: 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

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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).

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1065

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonezja, 10430
        • Rekrutacyjny
        • Cipto Mangunkusumo National General Hospital (RSCM)
        • Kontakt:
        • Główny śledczy:
          • Adhrie Sugiarto, MD, SpAn-KIC
    • West Java
      • Depok, West Java, Indonezja, 16424
        • Zakończony
        • Universitas Indonesia Hospital (RS UI)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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).

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Area under the receiver operating characteristic curve (AUROC) of machine learning models for predicting extubation failure
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Accuracy of machine learning models for predicting extubation failure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 września 2024

Zakończenie podstawowe (Szacowany)

23 stycznia 2027

Ukończenie studiów (Szacowany)

31 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

18 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 października 2026

Pierwszy wysłany (Rzeczywisty)

5 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • IndonesiaUAnes0897

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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