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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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)…

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Computerized health report (CHR)

Spontaneous breathing test should have been performed

Disqualifiers

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.

Trial population

All patient admited in Intensive Care/Critical Care who needed ventilatory support, whatever the etiology requiring it.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Spontaneous ventilation test

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Spontaneous Breathing Test1 intervention
Group B: Non Spontaneous Breathing Test1 intervention

Trial outcomes

Primary outcomes

1

Prediction of the spontaneous breathing test outcome.

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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