Automatic detection of breathlessness in adults on mechanical ventilation
Official title: Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
Run by Hospital de Clinicas José de San Martín · NCT07205952 · Data updated 2026-11-12
This project will try to use ventilator pressure and flow signals to detect breathlessness in non-communicative adults recently intubated and receiving mechanical ventilation in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Hospital de Clinicas José de San Martín Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Status | Recruiting |
| Started | November 22, 2024 |
| Main results expected | October 2025 |
| Study ends | October 2025 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT07205952 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) who were endotracheally intubated within the past 24 hours, are non-communicative, and are expected to require at least 24 hours of mechanical ventilation.
✕Probably not a fit
Patients receiving continuous neuromuscular blockade, those ventilated on Airway Pressure Release Ventilation (APRV) mode, or patients who can reliably report symptoms are unlikely to benefit from this automated detection approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll about 60 adult ICU patients who were endotracheally intubated within the previous 24 hours and are expected to need at least 24 hours of mechanical ventilation. Ventilator airway pressure and flow will be streamed into 131.1-second epochs for up to five days and a recursive algorithm will estimate inspiratory muscle pressure (Pmus) and calculate inspiratory effort time-pressure product (PmusPTP). Trained staff will collect MV-RDOS scores at least twice daily and time-match these subjective dyspnea ratings to the ventilator signal epochs to measure correlation and derive an ROC AUC threshold for PmusPTP equivalent to MV-RDOS > 2.6. Six supervised classifiers and a unanimity ensemble will be used to label discordant pairs, and ensemble-conflicting labels will be excluded from a secondary analysis.
Why it matters
Potential benefit: If successful, this work could provide a continuous, objective way to detect dyspnea at the bedside so clinicians can identify and treat breathlessness sooner.
How similar studies have gone: Prior physiologic and pilot studies using ventilator waveforms and machine learning have shown promise at estimating inspiratory effort, but continuous automated dyspnea detection in mechanically ventilated patients remains relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Adults of either sex (≥18 years) * Endotracheally intubated in the past 24 hours. * Expected to require ≥24 hours of mechanical ventilation. Exclusion criteria: * Continuous neuromuscular blockade. * Ventilated on Airway Pressure Release Ventilation mode.
Where it's running
-
Hospital de Clínicas de la Universidad de Buenos Aires
Buenos Aires, Buenos Aires, Argentina Recruiting
Study contacts
- Principal investigator: Guillermo Gutierrez — The George Washington University School of Medicine and Health Sciences
- Study coordinator: Guillermo Gutierrez, MD, PhD
- Email: gutier@gwu.edu
- Phone: 17035595843
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults
This study tests how different patient breathing efforts relate to breathlessness in adults on assisted mechanical ventilation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.