[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561011":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":11,"centralContacts":15,"locations":23,"responsibleParty":40,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":7,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",null,[9],{"type":6,"name":10,"description":10,"armGroupLabels":7,"otherNames":7},"There is no intervention",[12],{"name":13,"affiliation":5,"role":14},"Abraham Schoe, MD, PhD","PRINCIPAL_INVESTIGATOR",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":7,"email":20},"Willem Snoep, BSc","CONTACT","+31 (0)71-5262164","j.w.m.snoep@lumc.nl",{"name":13,"role":18,"phone":7,"phoneExt":7,"email":22},"a.schoe@lumc.nl",[24],{"facility":5,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"RECRUITING","Leiden","South Holland","2333ZA","Netherlands","NL",{"type":32,"coordinates":33},"Point",[34,35],4.49306,52.15833,{"lat":35,"lon":34},[38],{"name":17,"role":18,"phone":39,"phoneExt":7,"email":20},"+31715262164",{"type":14,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Abraham Schoe, MD, PhD.","MD, PhD, Principal Investigator",[44],{"name":45,"class":46},"Hamilton Medical AG","INDUSTRY","100561011","calibration-of-esophageal-balloon-catheter-in-spontaneous-and-mandatory-mechanical-ventilation-100561011",false,"NCT06584604","Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation","Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation (PESCA)","PESCA","Inclusion Criteria:\n\n* 18 years or older.\n* Mechanically ventilated in spontaneous mode.\n* Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5).\n* Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.).\n\nExclusion Criteria:\n\n* Medical condition that excludes the placement of a Pes catheter.\n* Allergic reaction against rocuronium in the past.\n* Pregnant.\n* RASS \\> -3","ALL","18 Years",{"count":58,"type":59},40,"ESTIMATED","1 Day","OBSERVATIONAL","Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.",[64,65,66],"Intensive Care Unit","Mechanical Ventilation","Critical Illness",[68,69,70,71,72],"Esophageal Pressure","Esophageal Balloon Catheter","Transpulmonary Pressure","Mandatory Ventilation","Support Ventilation","2025-04-17",{"date":75,"type":76},"2025-04-22","ACTUAL",{"date":78,"type":76},"2024-12-29",{"date":80,"type":59},"2027-01",{"name":5,"class":6},1]