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| Name | Class |
|---|---|
| Magnamed Tecnologia Medica S/A | UNKNOWN |
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This is a diagnostic study aiming to compare accuracy to detect and classify patient-ventilator dyssynchronies by a machine learning algorithm, compared to the gold-standard defined as dyssynchronies diagnosed and classified by mechanical ventilator and esophageal pressure waveforms analyzed by experts.
The main question of this study is:
• Are patient-ventilator dyssynchronies accurately detected and classified by an artificial intelligence algorithm when compared to experts analyzing esophageal pressure and mechanical ventilator waveforms?
This is a diagnostic, observational study, aiming to assess patient-ventilator dyssynchrony automated detection and classification by a machine learning algorithm. Accuracy of the machine learning algorithm will be compared with the gold-standard, defined as dyssynchronies detected and classified by mechanical ventilation experts.
Experts will analyzed airway pressure, flow, volume and esophageal pressure waveforms to detect and classify dyssynchronies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence Detection and Classification of Patient-Ventilator Dyssynchronies | This is a single arm study, since all subjects included will be exposed to both diagnostic methods (artificial intelligence and experts). The proposed diagnostic method is a machine learning algorithm integrated in the mechanical ventilator FlexiMag Max 700 (Magnamed, Brazil), which will continuously record data from mechanical ventilation of included subjects for a time period of up to 72 hours. The gold-standard involves esophageal pressure waveform recording and offline analysis by experts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence Detection and Classification of Patient-Ventilator Dyssynchronies | Device | Machine learning algorithm to detect and classify patient-ventilator dyssynchronies, which is integrated in the mechanical ventilator (Fleximag Max, Magnamed, Brazil). |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of the Artificial Intelligence algorithm | Sensitivity, specificity, positive predictive value, negative predictive value of the artificial intelligence algorithm to detect and classify patient-ventilator dyssynchronies. These accuracy indexes will be estimated for each kind of dyssinchrony: ineffective effort, autotriggering, double triggering, reverse triggering, reverse triggering with a double cycle | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pendelluft detection | Percentage of cycles with pendelluft detected with the artificial intelligence algorithm compared to the percentage of cycles with pendelluft detected with the esophageal pressure | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects under mechanical ventilation, with an assisted or assist-controlled mode, who are monitored with an esophageal pressure balloon due to clinical indication are eligible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glauco M Plens, MD | Contact | +5511982213020 | glaucomplens@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo LV Costa, MD, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute, University of São Paulo | Recruiting | São Paulo | São Paulo | 05403900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9449727 | Background | Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602. | |
| 10793162 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. |
| 33883458 | Background | Sousa MLEA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Clusters of Double Triggering Impact Clinical Outcomes: Insights From the EPIdemiology of Patient-Ventilator aSYNChrony (EPISYNC) Cohort Study. Crit Care Med. 2021 Sep 1;49(9):1460-1469. doi: 10.1097/CCM.0000000000005029. |
| 32032901 | Background | Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21. |
| 25693449 | Background | Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19. |
| 26017442 | Background | LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539. |