---
title: Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
nct_id: NCT07205952
overall_status: RECRUITING
sponsor: Hospital de Clinicas José de San Martín
study_type: OBSERVATIONAL
primary_condition: Dyspnea During Mechanical Ventilation
countries: Argentina
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07205952.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07205952"
ct_last_update_post_date: 2025-10-03
last_seen_at: "2026-05-12T06:43:00.984Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients

**NCT ID:** [NCT07205952](https://clinicaltrials.gov/study/NCT07205952)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Hospital de Clinicas José de San Martín
- **Conditions:** Dyspnea During Mechanical Ventilation
- **Start Date:** 2024-11-22
- **Completion Date:** 2025-10
- **CT.gov Last Update:** 2025-10-03

## 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.

## Eligibility

- **Sex:** 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.
```

## Arms

- **Adults on invasive mechanical ventilation** — Adults of either gender on invasive mechanical ventilation within the preceding 24 hours; and an anticipated need for continued ventilation for ≥24 additional hours. Exclusion criteria are continuous neuromuscular blockade at the time of screening and ventilation using airway pressure release ventilation (APRV).

## Primary Outcomes

- **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

- **Ventilator free days.** _(time frame: One year)_

## Locations (1)

- Hospital de Clínicas de la Universidad de Buenos Aires, Buenos Aires, Buenos Aires, Argentina — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital de clínicas de la universidad de buenos aires|buenos aires|buenos aires|argentina` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07205952.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07205952*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*