Recruiting OBSERVATIONAL NCT05886803

Medical-AI trial: predicting the success of a spontaneous breathing trial with machine learning — ICU ventilator weaning from biosignals and biomarkers (NCT05886803)

Centre Hospitalier Universitaire de Nice Updated 2026-06-29

An observational study of whether machine learning can predict, from biosignals and biomarkers, the success of the spontaneous breathing trial (SBT) used to test weaning from a ventilator in the ICU. Weaning takes up much of an ICU stay, and the first attempt reportedly fails in about 20%. Target 500; recruiting.

Trial overview (primary data)

  • StatusRecruiting
  • ConditionsWeaning From Mechanical Ventilation in Care Unit
  • InterventionsOTHER: Spontaneous ventilation test
  • SponsorCentre Hospitalier Universitaire de Nice
  • Target enrollment500 participants
  • Period2023-01-01 〜 2027-06-25

Key points

  • An observational study of whether ML can predict, from biosignals and biomarkers, the success of the spontaneous breathing trial (SBT) for ICU ventilator weaning.
  • Weaning can take up to half of an ICU stay; the first attempt is unsuccessful in about 20% of patients.
  • Mortality can reach 38% in the most difficult cases; weaning too early risks reintubation, too late invites complications and longer stays.
  • Framed as one example of AI decision support for clinicians (alongside septic-shock management and renal-failure prediction).
  • Target 500; recruiting. A predictive-performance evaluation, not a decision on extubation or an establishment of clinical use.
  • Weaning too early means reintubation and too late means complications; about 20 percent of first attempts fail.

1Weaning from mechanical ventilation

A critically ill patient who cannot breathe well on their own is supported by a ventilator. As they recover, the ventilator is withdrawn (weaning), but judging the right moment is hard. Weaning too early can force reintubation, adding burden and risk, while weaning too late invites ventilator-associated complications and a longer stay.

Weaning indeed occupies much of an ICU stay; per the summary, the first attempt fails in about 20% of patients, and mortality can reach 38% in the most difficult cases.

2Predicting the outcome of a breathing trial

So this study examines, as an observational study, whether the success of the spontaneous breathing trial (SBT, in which ventilator support is reduced to see how well the patient breathes on their own for a set time) can be predicted in advance with machine learning. Per the registry summary, it uses biosignals such as heart rate and respiration and biomarkers from blood as cues to estimate whether the SBT will succeed.

As research applying AI to clinical decision support grows, from managing septic shock to predicting renal failure, this study focuses that lens on the weaning decision. The target is 500, and it is recruiting.

3Too early, and too late

Weaning from a ventilator harms the patient if it errs in either direction. That difficulty is the reason prediction is sought.

Removing it too earlyRemoving it too late
The tube has to go back inComplications associated with ventilation follow
Burden and risk to the patient riseLength of stay extends
About 20 percent of first attempts failMortality can reach 38 percent among difficult-to-wean patients

The study therefore asks whether machine learning can predict, in advance, the success of the spontaneous breathing trial conducted before weaning. It is an observational study using biosignals such as heart rate and respiration together with blood biomarkers, targeting 500 cases. Weaning decisions rest heavily on experience and vary by institution and clinician.

Why it matters

Estimating in advance, from objective measures, a weaning decision that otherwise leans on experience could help reduce reintubation and unnecessary delays and allocate scarce critical-care resources. It offers a window into how ICU AI decision support is being validated (this trial evaluates predictive performance, not clinical use).

FAQ

What is a spontaneous breathing trial (SBT)?
A test in which ventilator support is reduced to see how well a patient breathes on their own for a set time. It helps judge whether weaning (extubation) is safe.
Does the AI decide extubation?
No. This observational study evaluates the performance of predicting SBT success; it does not decide actual extubation or establish clinical use.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Medical AI#Clinical trial#Machine learning#Critical care#Ventilator#Decision support
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