[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551756":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":10,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":76},{"fullName":5,"class":6},"Universidade Federal do Rio de Janeiro","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"low respiratory effort",null,"patients under low respiratory effort",[13],"Behavioral: low respiratory effort",{"label":15,"type":10,"description":16,"interventionNames":17},"high respiratory effort","patients under high respiratory effort",[18],"Behavioral: high respiratory effort",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"BEHAVIORAL","patients under respiratory effort lower than -1,5 cmH2O (P0,1) and\u002For -7 cmH2O (Pocc)",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":10},"patients under respiratory effort higher than -3,5 cmH2O (P0,1) and\u002For -15 cmH2O (Pocc)",[15],[28,32],{"name":29,"affiliation":30,"role":31},"Bruno Vilaça","manager of Physical Therapy team","STUDY_CHAIR",{"name":33,"affiliation":34,"role":31},"Bruno Guimarães","manager of physical therapy team",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Amanda Pereira da cruz","CONTACT","21971739472","amanda_pereiradacruz@yahoo.com.br",{"name":42,"role":38,"phone":43,"phoneExt":10,"email":44},"Pedro Leme Silva","2183430442","pedroleme@biof.ufrj.br",[46],{"facility":47,"status":48,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Gloria D'or hospital","RECRUITING","Rio de Janeiro","22211230","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-43.18223,-22.90642,{"lat":57,"lon":56},[60,62],{"name":37,"role":38,"phone":61,"phoneExt":10,"email":40},"55 21971739472",{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},{"type":64,"investigatorFullName":65,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","JOSE ROBERTO LAPA E SILVA","100551756","extremes-of-respiratory-effort-in-weaning-failure-from-mechanical-ventilation-a-prospective-observational-study-100551756",false,"NCT06464224","Extremes of Respiratory Effort in Weaning Failure From Mechanical Ventilation: a Prospective Observational Study","Are the Extremes of Respiratory Efforts During Assisted Ventilation Associated With Weaning Failure in Critical Ill Patients: a Prospective Observational Study","Inclusion Criteria:\n\n* Patients over 18 years old, admitted to the Glória D'or hospital, undergoing orotracheal intubation and invasive mechanical ventilation, in their first 7 years on spontaneous ventilation, who accept to participate in the study by signing the free and informed consent form (or by their legal responsible).\n\nExclusion Criteria:\n\n* • Neuromuscular disease;\n\n  * Phrenic nerve injury;\n  * MV for less than 24 hours;\n  * Previously tracheostomized patient;\n  * Age under 18;\n  * Use of neuromuscular blocker \\> 72h;\n  * COPD;\n  * Patients with pulmonary fibrosis;\n  * Pregnancy;\n  * Patient under palliative care;\n  * COVID-19 pneumonia;\n  * Patients reintubated after extubation in this hospitalization for less than 3 weeks.","ALL","18 Years",{"count":76,"type":77},1,"ESTIMATED","OBSERVATIONAL","The presence of high levels of respiratory effort in patients under mechanical ventilation may worsen the adjacent lung injury even after adapting protective ventilation. Primary outcome: To evaluate the failure rate of weaning from IMV and its relationship with the lower and upper extremes of respiratory effort and the upper extreme of dynamic pulmonary stress during the first 7 days of spontaneous ventilation. Analyze the influence of these extremes based on the thresholds of Pocc, P0.1 and their derivatives Pmus, Ptp, din and MP: in relation to days off MV (in the 28-day interval); Total weaning time; Rate and time for tracheostomy; Length of stay in the ICU and hospital; In-hospital mortality rate. CAAE: 78185823.4.0000.5249. Prospective multicenter observational study, carried out in the ICUs of Glória D'or and Niteroi D'or hospitals, from January 2024 to July 2026, in patients over 18 years old, undergoing orotracheal intubation and IMV, in their first 7 days on spontaneous ventilation. Hypothesis: Extremes of respiratory effort and dynamic pulmonary stress would be associated with a higher rate of weaning from IMV, as well as longer time on IMV and subsequent longer hospital stay.",[81,82],"Mechanical Ventilation Pressure High","Weaning Failure",[84,85],"respiratory drive","respiratory effort","2024-07-19",{"date":88,"type":89},"2024-07-23","ACTUAL",{"date":91,"type":89},"2024-04-01",{"date":93,"type":77},"2026-07",{"name":5,"class":6}]