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OpenTrials
Completed

NCT Number: NCT06333002

Machine Learning Model to Predict Outcome in Acute Hypoxemic Respiratory Failure

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Ciudad Real, Ciudad Real, Spain

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About this study

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in AHRF patients on mechanical ventilation (MV). Few studies have investigated the prediction of mortality in patients with AHRF.

For model development, the investigators will extract data for the first 2 days after diagnosis of AHRF from patients included in the de-identified database of the PANDORA cohort. We had a database with 2,000,000 anonymized and dissociated demographics and clinical, data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) from 22 Spanish hospitals and coordinated by the principal investigator (JV). The investigators will follow the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines for model prediction. We will screen collected variables employing a genetic algorithm variable selection method to achieve parsimony. We evaluated the minimum number of variables models using logistic regression and 4 supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. We will use a 5-fold cross-validation in the dataset of 1,000 patients selected randomly in training data (80%) and testing data (20%). For external validation, we will use the remaining 241 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • endotracheal intubation plus mechanical ventilation (MV)
  • PaO2/FiO2 ratio ≤300 mmHg under MV with positive end-expiratory pressure (PEEP) ≥5 cmH2O and FiO2 ≥0.3.

Exclusion criteria

  • Post-operative patients ventilated <24 h
  • Brain death patients.

Treatment and study plan

machine learning analysis

Other

We will use robust machine learning approaches, such as Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron.

Other names: Logistic regression, cross validation, and area under the ROC curves

Primary outcomes

  1. ICU mortality

    Time frame: up to 100 weeks (from inclusion to death or diascharge from intensive care unit

    death in the intensive care unit

Secondary outcomes

  1. MV duration

    Time frame: up to 100 weeks (from inclusion to extubation)

    duration of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Registry information

Official study title

Developing an Optimal Machine Learning Model to Predict ICU Outcome in Patients With Acute Hypoxemic Respiratory Failure

Acronym: MEMORIAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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