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NCT Number: NCT05886803

Prediction of the Spontaneous Breathing Test Success Using Biosignal and Biomarker in Critical Care Unit by a Machine Learning Approach

Context:

Several authors have been interested in applying Artificial Intelligence (AI) to medicine, using various Machine Learning (ML) techniques: managing septic shock, predicting renal failure... [1, 2] AI has an important place in decision support for clinicians [3]. The weaning period is a really important time in the management of a patient on mechanical ventilation and can take up to half of the time spent in intensive care unit. The first weaning attempt is unsuccessful in 20% of patients However, mortality can be as high as 38% in patients with the most difficult weaning [4]. Only a few studies have looked at the application of machine learning in this area, and only one has looked at the use of biosignals (cardiac rate, ECG, ventilatory parameters…) [5-7]. To improve morbidity, mortality and reduce length of stay, it is essential to be able to predict the success of the spontaneous breathing test and extubation.

Investigators propose to develop a predictive algorithm for the success of a ventilatory weaning test based on biosignal records and others features.

Methods:

It is a critical care, oligo-centric and retrospective study the investigators included biosignal variables extracted from the electronic medical record, such as respiratory (RR, minute volume...), cardiac (systolic pressure, heart rate...), ventilator parameters and other discrete variables (age, comorbidity...). Most biosignal variables are minute-by-minute records. Recording starts 48 hours before the test and stops at the start of the weaning test. The investigators extracted features from these records, combined them with other biomarkers, and applied several machine learning algorithms: Logistic Regression, Random Forest Classifier, Support Vector Classifier (SVC), XGBoost, and Light Gradient Boosting Method (LGBM)…

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Computerized health report (CHR)
  • Spontaneous breathing test should have been performed

Exclusion criteria

  • Spontaneous breathing test has not been performed,
  • Biosignal (cardiac, respiratory) are not registered in the CHR
  • Patient died before the spontaneous breathing test
  • Opposition to the study has been expressed.

Treatment and study plan

Spontaneous ventilation test

Other

The purpose is to mimic ventilation conditions after extubation and thus to help the clinician predict the outcome of an extubation decision.

Primary outcomes

  1. Prediction of the spontaneous breathing test outcome.

    Time frame: 2 years

    Two modalities of test are performed in clinical : either a T-tube test or a spontaneous ventilation test at low level of Inspiratory Support and PEEP (7AI 4PEEP, 7Ai 0PEEP).

    A successful weaning test is defined by the absence of the following criteria at the end of the test: (i) increase in respiratory rate > 35cpm, (ii) SpO2 <90%, (iii) change of more than 20% in heart rate or blood pressure, (iv) modification of consciousness.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean DELLAMONICA

CONTACT

[email protected]

Romain LOMBARDI

CONTACT

[email protected]

0669032616 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jun 2, 2023
Registry last updated
Jun 29, 2026

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

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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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