Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dyspnea During Mechanical Ventilation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score. [Time frame: One year]
Secondary outcome measures (1)
- Ventilator free days. [Time frame: One year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Argentina · 1 center
- Hospital de Clínicas de la Universidad de Buenos Aires — Buenos Aires
Publications
- Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042S PMID 22336677
- Gutierrez G. A non-invasive method to monitor respiratory muscle effort during mechanical ventilation. J Clin Monit Comput. 2024 Oct;38(5):1125-1134. doi: 10.1007/s10877-024-01164-z. Epub 2024 May 11. PMID 38733504
- Gutierrez G. A novel method to calculate compliance and airway resistance in ventilated patients. Intensive Care Med Exp. 2022 Dec 30;10(1):55. doi: 10.1186/s40635-022-00483-2. PMID 36581716
- Decavele M, Rozenberg E, Nierat MC, Mayaux J, Morawiec E, Morelot-Panzini C, Similowski T, Demoule A, Dres M. Respiratory distress observation scales to predict weaning outcome. Crit Care. 2022 Jun 6;26(1):162. doi: 10.1186/s13054-022-04028-7. PMID 35668459
- Demoule A, Decavele M, Antonelli M, Camporota L, Abroug F, Adler D, Azoulay E, Basoglu M, Campbell M, Grasselli G, Herridge M, Johnson MJ, Naccache L, Navalesi P, Pelosi P, Schwartzstein R, Williams C, Windisch W, Heunks L, Similowski T. Dyspnoea in acutely ill mechanically ventilated adult patients: an ERS/ESICM statement. Eur Respir J. 2024 Feb 22;63(2):2300347. doi: 10.1183/13993003.00347-2023. PMID 38387998
Identifiers
NCT: NCT07205952 · 1337-25