- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07918924
Predicting Extubation Failure Using Machine Learning
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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Adhrie Sugiarto
- Telefoonnummer: +62213157008
- E-mail: adhrie@gmail.com
Studie Contact Back-up
- Naam: Jefferson Hidayat
- Telefoonnummer: +62213157008
- E-mail: Jeffersonhidayat@yahoo.com
Studie Locaties
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesië, 10430
- Werving
- Cipto Mangunkusumo National General Hospital (RSCM)
-
Contact:
- Medical and Health Research Ethics Committee of RSCM
- Telefoonnummer: 021-315-7008
- E-mail: penelitian.anestesirscm2@gmail.com
-
Hoofdonderzoeker:
- Adhrie Sugiarto, MD, SpAn-KIC
-
-
West Java
-
Depok, West Java, Indonesië, 16424
- Voltooid
- Universitas Indonesia Hospital (RS UI)
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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).
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUROC) of machine learning models for predicting extubation failure
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Accuracy of machine learning models for predicting extubation failure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Kulkarni AP, Agarwal V. Extubation failure in intensive care unit: predictors and management. Indian J Crit Care Med. 2008 Jan;12(1):1-9. doi: 10.4103/0972-5229.40942.
- Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.
- Epstein SK. Decision to extubate. Intensive Care Med. 2002 May;28(5):535-46. doi: 10.1007/s00134-002-1268-8. Epub 2002 Apr 12.
- Epstein SK. Extubation failure: an outcome to be avoided. Crit Care. 2004 Oct;8(5):310-2. doi: 10.1186/cc2927. Epub 2004 Aug 10.
- Saeed F, Lasrado S. Extubation. 2023 Feb 9. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539804/
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IndonesiaUAnes0897
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .