Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients
NCT ID: NCT07205952
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-11-22
2025-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Endotracheally intubated in the past 24 hours.
* Expected to require ≥24 hours of mechanical ventilation.
Exclusion Criteria
* Ventilated on Airway Pressure Release Ventilation mode.
ALL
No
Sponsors
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Hospital de Clinicas José de San Martín
OTHER
Responsible Party
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Celica Irrazabal
Director, Intensive Care Unit and Co-Principal Investigator
Principal Investigators
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Guillermo Gutierrez
Role: PRINCIPAL_INVESTIGATOR
The George Washington University School of Medicine and Health Sciences
Celica Irrazabal, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas José de San Martín
Locations
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Hospital de Clínicas de la Universidad de Buenos Aires
Buenos Aires, Buenos Aires, Argentina
Countries
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Central Contacts
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Facility Contacts
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References
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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.201111-2042ST.
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.
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.
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.
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. Print 2024 Feb.
Other Identifiers
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1337-25
Identifier Type: -
Identifier Source: org_study_id
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