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Completed

NCT Number: NCT05993377

Prediction of Duration of Mechanical Ventilation in ARDS

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, NCT022288949, NCT02836444, NCT03145974), aimed to characterize the best early scenario during the first three days of diagnosis to predict duration of mechanical ventilation in the intensive care unit (ICU) using supervised machine learning (ML) 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 an important cause of morbidity, mortality, and costs in intensive care units (ICUs) worldwide. Most ARDS patients require mechanical ventilation (MV). Few studies have investigated the prediction of MV duration of ARDS.

For model description and testing, the investigators will extract data from he first three ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,000 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 techniques will be implemented [Random Forest (RF), eXtreme Gradient Boosting (XGBoost), and Logistic regression analysis) for the development and accuracy of prediction models. Disease progression will be tracked along those 3 ICU days to assess lung severity according to Berlin criteria. 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 calculation several statistics, such as sensitivity, specificity, positive predictive value, negative value for each model. The investigators will select the best early prediction model with data captured on the 1st, 2nd, or 3rd day.

Who can participate

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

Inclusion criteria

  • Berlin criteria for moderate to severe acute respiratory distress syndrome

Exclusion criteria

  • Postoperative patients ventilated <24h
  • brain death patients

Treatment and study plan

Logistic regression Cross validation Area under the RIC curves Machine learning analysis. .

Other

we will use robust machine learning approaches, such as Random Forest and XGBoost.

Primary outcomes

  1. Days on mechanical ventilation

    Time frame: from diagnosis to extubation

    Duration of mechanical ventilation

Secondary outcomes

  1. ICU mortality

    Time frame: up to 24 weeks

    mortality in the intensive care unit

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • Cardiff University
  • Leiden University Medical Center
  • Unity Health Toronto

Registry information

Official study title

Predicting Length of Mechanical Ventilation in Moderate-to-severe Acute Respiratory Distress Syndrome Using Machine Learning

Acronym: PIONEER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Mar 20, 2024

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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