[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610878":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hospital de Alta Complejidad en Red","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alveolar Opening Maneuver and PEEP Titration (AOM+P)",null,"Patients under invasive mechanical ventilation for pediatric acute respiratory distress syndrome (PARDS) who undergo a standardized alveolar opening maneuver followed by decremental PEEP titration according to institutional protocol. The maneuver consists of stepwise increases in PEEP until reaching a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by decremental PEEP titration to determine the optimal level based on driving pressure and oxygen saturation. The procedure is performed once clinically indicated, with continuous hemodynamic and oxygenation monitoring.",[13],"Procedure: Alveolar Opening Maneuver and PEEP Titration (AOM+P)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"PROCEDURE","Standardized ventilatory procedure performed in pediatric patients under invasive mechanical ventilation with acute respiratory distress syndrome (PARDS). The intervention consists of a controlled alveolar opening maneuver with stepwise PEEP increments up to a plateau pressure of 35 cmH₂O (or up to 40 cmH₂O in patients with reduced chest wall compliance), maintained for 2 minutes, followed by a decremental PEEP titration to determine the optimal PEEP level based on driving pressure and oxygenation response. The procedure is performed once clinically indicated, under continuous hemodynamic and oxygen monitoring, according to the institutional safety protocol.",[9],[20],"Alveolar Opening Protocol, PEEP Titration Procedure, AOM+P Institutional Protocol",[22,26],{"name":23,"affiliation":24,"role":25},"Jose Garcia Urrutia, BCS","Hospital de Alta Complejidad Cuenca Alta \"Néstor Kirchner\", Buenos Aires, Argentina","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Belen Castelli, BCS",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Maria Belén B castelli, BCS","CONTACT","+54 2227442582","investigacion@hospitalcuencaalta.org.ar",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":10},"Hospital Cuenca Alta Néstor Kirchner","RECRUITING","Canuelas","Buenos Aires","B1814","Argentina","AR",{"type":44,"coordinates":45},"Point",[46,47],-58.76205,-35.05379,{"lat":47,"lon":46},{"type":25,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Belen Castelli","Physical Therapy","100610878","complications-of-the-alveolar-opening-maneuver-in-children-on-mechanical-ventilation-100610878",false,"NCT07233304","Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation","Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome","Inclusion criteria:\n\n* Patients under 14 years of age admitted to the HCANK PICU\n* More than 4 hours of invasive mechanical ventilation (IMV)\n* An oxygenation index (OI) ≥4 or an oxygen saturation index (OSI) ≥5\n* Indication for ARM and PEEP as determined by the treating team\n\nExclusion criteria:\n\n* Predicted body weight (PBW) \\>45.5 kg\n* Recent pulmonary resection surgery (\\\u003C7 days)\n* Presence of broncho-pleural fistula or peri-tube leak \\>25% of the tidal volume\n* Hemoglobin decline \\\u003C7 g\u002FdL\n* Patients with congenital or acquired heart diseases with significant intracardiac shunt.","ALL","1 Month","14 Years",{"count":63,"type":64},143,"ESTIMATED","1 Day","OBSERVATIONAL","The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.",[69,70,71,72,73,74],"Positive End-expiratory Pressure (PEEP)","Oxygenation Index","Pediatric Intensive Care Unit","Pediatric Acute Lung Injury","Respiratory Distress Syndrome, Pediatric","Complication","2025-11-14",{"date":77,"type":78},"2025-11-18","ACTUAL",{"date":80,"type":78},"2025-08-18",{"date":82,"type":64},"2026-08",{"name":5,"class":6},1]