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The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.
Inclusion criteria:
Exclusion criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the pressure-time-product of inspiratory effort and the MV-RDOS score. | 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). | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days. | The number of days from the last day of invasive mechanical ventilation to day 28. | One year |
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Inclusion criteria:
Exclusion criteria:
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Adults of either sex with respiratory failure of any cause on invasive mechanical ventilation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Gutierrez, MD, PhD | Contact | 17035595843 | gutier@gwu.edu | |
| Celica Irrazabal, MD | Contact | 54 9 11 4969 8043 | clirrazabal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Gutierrez | The George Washington University School of Medicine and Health Sciences | Principal Investigator |
| Celica Irrazabal, MD | Hospital de ClÃnicas José de San MartÃn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de la Universidad de Buenos Aires | Recruiting | Buenos Aires | Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336677 | Background | 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. | |
| 38733504 |
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January 1, 2026 through December 31, 2026
Data are available to qualified investigators on reasonable request by emailing the principal investigator
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| Background |
| 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. |
| 36581716 | Background | 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. |
| 35668459 | Background | 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. |
| 38387998 | Background | 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. |