[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554063":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":23,"locations":33,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Pressure Support Variation","Patients shall be submitted to pressure support variation in a randomly assigned manner. First 30 minutes after plethysmogram stabilization shall be recorded at clinical pressure support. Next, a blood gas sample shall be collected by a nurse or a physician, and three inspiratory pauses of at least 2 seconds shall be performed in between eight respiratory cycles. Next three expiratory pauses shall be performed in between eight respiratory cycles. All data shall be recorded and analysed offline. Subsequently the same sequence of events shall be performed at a 50% higher pressure support and at a 50% lower pressure support. The sequence in which this will happen shall be randomly assigned (first lower PS vs higher PS or first higher PS vs lower PS).",[12],"Other: Pressure Support Variation and Calculation of Respiratory Mechanics",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"Pressure Support Variation and Calculation of Respiratory Mechanics","Patients will be submitted to different levels of pressure support (PS) in a randomly assigned order. First 30 minutes shall be recorded at the clinical PS. Next, blood gas samples shall be collected. Subsequently, three inspiratory pauses of at least 2 seconds shall be performed with an interval of at least 8 respiratory cycles between them. The same shall be performed with three expiratory pauses. Next, the PS shall be varied to 50% less or 50% more than clinical PS (based on randomization) and the same procedures shall be performed after 30 minutes of data recording (blood gas sample collection, inspiratory and expiratory pauses). All data shall be analyzed offline using a software that will be able to compare three different methods to calculate Pendelluft magnitude based on the literature. After completion of the protocol, ventilatory parameters shall be returned to the original settings. If the patient becomes tachypneic during lower PS, the protocol shall be interrupted.",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Marcelo BP Amato","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Marcelo BP Amato, MD PhD","CONTACT","3061-7361","marcelo.amato@hc.fm.usp.br",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Emily Sofia Ceron","+5511967259925","emily.s.ceron11@gmail.com",[34],{"facility":35,"status":36,"city":37,"state":18,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP","RECRUITING","São Paulo","05403-900","Brazil","BR",{"type":42,"coordinates":43},"Point",[44,45],-46.63611,-23.5475,{"lat":45,"lon":44},[48,50,54],{"name":49,"role":26,"phone":27,"phoneExt":18,"email":28},"Marcelo BP Amato, MD, PhD",{"name":51,"role":26,"phone":52,"phoneExt":18,"email":53},"Ana C Cardoso dos Santos, PT","+5511968022077","cardosocsfisio@gmail.com",{"name":55,"role":22,"phone":18,"phoneExt":18,"email":18},"Marcelo C Amato, MD, PhD",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100554063","comparison-of-different-methods-to-calculate-pendelluft-by-electrical-impedance-tomography-in-mechanically-ventilated-patients-100554063",false,"NCT06494215","Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients","Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode","Inclusion Criteria:\n\n* Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)\n\nExclusion Criteria:\n\n* Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.","ALL","18 Years",{"count":68,"type":69},15,"ESTIMATED","INTERVENTIONAL",[72],"NA","The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.",[75,76,77,78],"Asynchrony, Patient-Ventilator","ARDS","Respiratory Insufficiency","Respiratory Effort-Related Arousal | Patient | Respiratory Measures and Ventilator Management",[80,81,82,76,83,84],"Pendelluft","Ventilator-patient asynchrony","Patient self-induced lung injury","Respiratory failure","Electrical Impedance Tomography","2024-07-02",{"date":87,"type":88},"2024-07-10","ACTUAL",{"date":90,"type":88},"2024-06-11",{"date":92,"type":69},"2025-06-11",{"name":5,"class":6},1]