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NCT Number: NCT07205952

Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score.

    Time frame: One year

    The 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 outcomes

  1. Ventilator free days.

    Time frame: One year

    The number of days from the last day of invasive mechanical ventilation to day 28.

Study contacts

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

Celica Irrazabal, MD

CONTACT

[email protected]

54 9 11 4969 8043

Guillermo Gutierrez, MD, PhD

CONTACT

[email protected]

17035595843

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas José de San Martín

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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