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Completed

NCT Number: NCT05611177

Predicting ICU Mortality in ARDS Patients

The investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in several published cohorts (NCT00736892, NCT02288949, NCT02836444, NCT03145974), aimed to characterize the best early model to predict duration of mechanical ventilation and mortality in the intensive care unit (ICU) after ARDS diagnosis using machine learning approaches.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Dr. Negrin, Las Palmas de Gran Canaria, Las Palmas, Spain

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About this study

The acute respiratory distress syndrome (ARDS) is a severe form of acute hypoxemic respiratory failure in Critical Care Units worldwide. Most ARDS patients requiere mechanical ventilation (MV). Few studies have investigated the prediction of MV duration and mortality of ARDS.

For model description, the investigators will extract data from the first two ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,303 mechanically ventilated patients enrolled in several observational cohorts in Spain, coordinated by the principal investigator (JV), and funded by the Instituto de Salud Carlos III (ISCIII). The investigators will follow the TRIPOD guidelines and machine learning tecniques will be implemented (Random Forest, XGBoost, Logistic regression analysis, and/or neural networks) for development of the prediction model, and the accuracy will be compared to those of existing scoring systems for assessing ICU severity (APACHE II, SOFA) and the PaO2/FiO2 ratio. For external validation, the investigators will use 303 patients enrolled in a contemporary observational study (NCT03145974). The investigators will evaluate the accuracy of prediction models by calculating the respective confusion matrices and several statistics such as sensitivity, specificity, positive predictive value, and negative predictive value for mortality and duration of MV. Investigators will select the best probabilistic model with a minimum number of clinical variables.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Berlin criteria for moderate to severe ARDS

Exclusion criteria

  • Postoperative patients ventilated <24h; brain death patients.

Treatment and study plan

machine learning analysis

Other

We will use robust machine learning approaches, such as Random Forest, XGBoost or Neural Networks.

Other names: Logistic regression, cross-validation, are aunder the ROC curves

Primary outcomes

  1. ICU mortality

    Time frame: up to 6 months

    mortality in the intensive care unit

Secondary outcomes

  1. MV duration

    Time frame: from ARDS diagnosis to extubation

    Duration of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study title

Predicting Mortality in Patients With the Acute Respiratory Distress Syndrome Using Machine Learning

Acronym: POSTCARDS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Aug 21, 2023

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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