[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608776":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":17,"overallOfficials":27,"centralContacts":35,"locations":44,"responsibleParty":56,"collaborators":17,"id":59,"slug":17,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":17,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":17,"maxAge":17,"enrollmentInfo":65,"targetDuration":17,"studyType":68,"phases":17,"briefSummary":69,"conditions":70,"keywords":17,"overallStatus":47,"whyStopped":17,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hospital de Clinicas José de San Martín","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14],{"measure":15,"description":16,"timeFrame":12},"Ventilator free days.","The number of days from the last day of invasive mechanical ventilation to day 28.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Inclusion criteria:\n\n* Adults of either sex (≥18 years)\n* Non-c0mmunicative, endotracheally intubated in the past 24 hours.\n* Expected to require ≥24 hours of mechanical ventilation.\n\nExclusion criteria:\n\n* Continuous neuromuscular blockade.\n* Ventilated on Airway Pressure Release Ventilation mode.\n\nVentilator 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).\n\nTrained 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.\n\nUsing 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\u002Fspecificity.\n\nTo 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.\n\nPrimary outcome will be Pearson's R2 (PmusPTP vs MV-RDOS). Secondary outcome will be 28-day ventilator-free days.","Adults of either sex with respiratory failure of any cause on invasive mechanical ventilation.",[24],{"label":25,"type":17,"description":26,"interventionNames":17},"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).",[28,32],{"name":29,"affiliation":30,"role":31},"Guillermo Gutierrez","The George Washington University School of Medicine and Health Sciences","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Celica Irrazabal, MD","Hospital de Clínicas José de San Martín",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"Guillermo Gutierrez, MD, PhD","CONTACT","17035595843","gutier@gwu.edu",{"name":33,"role":38,"phone":42,"phoneExt":17,"email":43},"54 9 11 4969 8043","clirrazabal@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":17,"country":49,"countryCode":50,"cosmosGeoPoint":17,"geoPoint":17,"contacts":51},"Hospital de Clínicas de la Universidad de Buenos Aires","RECRUITING","Buenos Aires","Argentina","AR",[52,53],{"name":33,"role":38,"phone":42,"phoneExt":17,"email":43},{"name":54,"role":38,"phone":17,"phoneExt":17,"email":55},"Carlos G Sosa, MD","sosac29l@gmail.com",{"type":31,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Celica Irrazabal","Director, Intensive Care Unit and Co-Principal Investigator","100608776",false,"NCT07205952","Automatic Detection of Dyspnea in Mechanically Ventilated, Critically Ill Patients","Inclusion criteria:\n\n* Adults of either sex (≥18 years)\n* Endotracheally intubated in the past 24 hours.\n* Expected to require ≥24 hours of mechanical ventilation.\n\nExclusion criteria:\n\n* Continuous neuromuscular blockade.\n* Ventilated on Airway Pressure Release Ventilation mode.","ALL",{"count":66,"type":67},60,"ESTIMATED","OBSERVATIONAL","The investigators will conduct a prospective, observational, two-center ICU study of 60 subjects on mechanical ventilation with respiratory failure of any cause.",[71],"Dyspnea During Mechanical Ventilation","2025-09-25",{"date":74,"type":75},"2025-10-03","ACTUAL",{"date":77,"type":75},"2024-11-22",{"date":79,"type":67},"2025-10",{"name":5,"class":6},1]