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Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07205952
Enrollment
60
Registered
2025-10-03
Start date
2024-11-22
Completion date
2025-10-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea During Mechanical Ventilation

Brief summary

The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.

Detailed description

Inclusion criteria: * Adults of either sex (≥18 years) * Non-c0mmunicative, 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. Ventilator measured airway pressure and flow signals will be streamed at 31.25 Hz into 131.1-s time windows (epochs) for up to 5 days. A recursive algorithm will compute individual breath's inspiratory effort (Pmus) and calculate the inspiratory effort time-pressure product (PmusPTP cmH₂O·s·min-¹). Trained staff will assess the Mechanical Ventilation-Respiratory Distress Observation Scale (MV-RDOS), an intermittent and subjective assessment of dyspnea, at least twice daily. These will be time-matched to the airway signal epochs to determine their degree of correlation by Pearsons R2. Using receiver operating characteristic (ROC) area under the curve (AUC) analysis, the investigators will determine a dyspnea threshold for PmusPTP equivalent to the dyspnea cut-off for MV-RDOS \> 2.6, and report sensitivity/specificity. To address possible label misclassification, the investigators will train six supervised classifiers on concordant data pairs and apply a unanimity ensemble to label discordant pairs as dyspneic, not dyspneic and undetermined. Ensemble determined labels conflicting with those classified by MV-RDOS will be excluded from a secondary analysis. Primary outcome will be Pearson's R2 (PmusPTP vs MV-RDOS). Secondary outcome will be 28-day ventilator-free days.

Interventions

None listed

Sponsors

Hospital de Clinicas José de San Martín
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.One yearThe degree of correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score will be determined with Pearson's coefficient of determination (R2).

Secondary

MeasureTime frameDescription
Ventilator free days.One yearThe number of days from the last day of invasive mechanical ventilation to day 28.

Countries

Argentina

Contacts

Primary ContactGuillermo Gutierrez, MD, PhD
gutier@gwu.edu17035595843
Backup ContactCelica Irrazabal, MD
clirrazabal@gmail.com54 9 11 4969 8043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026