[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544492":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":151,"collaborators":153,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":170,"sex":176,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":18,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Seventh Medical Center of PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"prone position during ECMO in pediatric ARDS","EXPERIMENTAL","Procedure: Prone positioning The process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring the implementation of prone positioning. The process of monitoring includes ECMO flow and vital signs. The second person is in charge of the patient's head, including endotracheal intubation, ventilator lines, and jugular ECMO cannula. The third person is responsible for femoral ECMO cannula and central venous line. The fourth to sixth individuals are responsible for rotating the patient's torso towards the side without an ECMO tube. Before initiating prone ventilation, pressure ulcer protection patches should be placed to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation. Each session should last between 16 to 24 hours.",[13],"Procedure: prone position",{"label":15,"type":16,"description":17,"interventionNames":18},"supine position during ECMO in pediatric ARDS","NO_INTERVENTION","Procedure: Supine position Patients assigned to supine will remain in a semi-recumbent position.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","prone position","The process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring. The process of monitoring includes ECMO flow and the vital signs. The second person is in charge of the patient's head, including endotracheal intubation, ventilator lines, and jugular ECMO cannula. The third person is responsible for femoral ECMO cannula and central venous line. The fourth to sixth individuals are responsible for rotating the patient's torso towards the side without an ECMO tube. Before initiating prone ventilation, pressure ulcer protection patches should be placed on the patient's forehead, ears, anterior chest, and iliac crest to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation until their condition improves enough to discontinue ECMO support. Each session should last between 16 to 24 hours.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Xiaoyang Hong, M.D.","CONTACT","13311057633","jyhongxy@163.com",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Zhe Zhao","18500179885","derekpicu@outlook.com",[36,53,68,82,96,110,125,136],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Seventh medical center of Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100700","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51,52],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},{"facility":54,"status":38,"city":55,"state":56,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Gansu Provincial Maternal and Child Health Care Hospital","Lanzhou","Gansu","730050",{"type":45,"coordinates":59},[60,61],103.83987,36.05701,{"lat":61,"lon":60},[64],{"name":65,"role":28,"phone":66,"phoneExt":18,"email":67},"Weikai Wang, M.D.","0931-5188650","35487284@qq.com",{"facility":69,"status":38,"city":70,"state":71,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The Second School of Clinical Medicine, Southern Medical University","Guangzhou","Guangdong",{"type":45,"coordinates":73},[74,75],113.25,23.11667,{"lat":75,"lon":74},[78],{"name":79,"role":28,"phone":80,"phoneExt":18,"email":81},"Yuxiong Guo, M.D.","13423661583","2003kellylaw@163.com",{"facility":83,"status":38,"city":84,"state":71,"zip":85,"country":42,"countryCode":43,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Shenzhen Bao'an Maternity & Child Health Hospital","Shenzhen","518100",{"type":45,"coordinates":87},[88,89],114.0683,22.54554,{"lat":89,"lon":88},[92],{"name":93,"role":28,"phone":94,"phoneExt":18,"email":95},"Ping Jin, M.D.","18025493395","yanyanab2004@aliyun.com",{"facility":97,"status":38,"city":98,"state":99,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The People's Hospital of Guangxi Zhuang Autonomous Region","Nanning","Guangxi",{"type":45,"coordinates":101},[102,103],108.31667,22.81667,{"lat":103,"lon":102},[106],{"name":107,"role":28,"phone":108,"phoneExt":18,"email":109},"Hanwu Huang, M.D.","15107710327","2503133021@qq.com",{"facility":111,"status":38,"city":112,"state":113,"zip":114,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Henan Children's Hospital","Zhengzhou","Henan","450014",{"type":45,"coordinates":116},[117,118],113.64861,34.75778,{"lat":118,"lon":117},[121],{"name":122,"role":28,"phone":123,"phoneExt":18,"email":124},"Feng Wang, M.D.","0371-85515892","wang.f365@163.com",{"facility":126,"status":38,"city":112,"state":113,"zip":127,"country":42,"countryCode":43,"cosmosGeoPoint":128,"geoPoint":130,"contacts":131},"Henan Provincial People's Hospital","463599",{"type":45,"coordinates":129},[117,118],{"lat":118,"lon":117},[132],{"name":133,"role":28,"phone":134,"phoneExt":18,"email":135},"Donglaing Cheng, M.D.","18838083052","41655181@qq.com",{"facility":137,"status":38,"city":138,"state":139,"zip":140,"country":42,"countryCode":43,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Xi'an Children's Hospital","Xi'an","Shaanxi","710002",{"type":45,"coordinates":142},[143,144],108.92861,34.25833,{"lat":144,"lon":143},[147],{"name":148,"role":28,"phone":149,"phoneExt":18,"email":150},"Yi Wang, M.D.","18591953652","wangyichengxian@163.com",{"type":152,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[154,155,158,160,161,163,165],{"name":54,"class":6},{"name":156,"class":157},"Xian Children's Hospital","OTHER_GOV",{"name":159,"class":6},"People's Hospital of Guangxi Zhuang Autonomous Region",{"name":126,"class":6},{"name":162,"class":6},"Guangdong Provincial People's Hospital",{"name":164,"class":6},"Shenzhen Bao'an Maternal and Child Health Hospital",{"name":166,"class":167},"Zhengzhou Children's Hospital","UNKNOWN","100544492","prone-position-during-ecmo-in-pediatric-patients-with-severe-ards-100544492",false,"NCT06369584","Prone Position During ECMO in Pediatric Patients With Severe ARDS","Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study","PEPAD","Inclusion Criteria:\n\n* Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.\n* Informed consent obtained from the child's direct\u002Flegal guardian\n\nExclusion Criteria:\n\n1. Age \\\u003C 1 month or \\> 18 years old.\n2. ECMO initiated for more than 48 hours.\n3. Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).\n4. Presence of irreversible brain injury or intracranial hypertension.\n5. Children with irreversible lung disease awaiting lung transplantation.\n6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).\n7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.\n8. Other contraindications for performing percutaneous cannulation.\n9. Liver failure.\n10. Burn area \\>20% body surface area (BSA).","ALL","1 Month","18 Years",{"count":180,"type":181},7,"ESTIMATED","INTERVENTIONAL",[184],"NA","In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).\n\nIn 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.\n\nECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P\u002FF\\\u003C80mmHg or Oxygen Index (OI) \\>40 for over 4 hours or OI \\>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.",[187,188],"Pediatric Acute Respiratory Distress Syndrome","Extracorporeal Membrane Oxygenation",[190,191,192],"Extracorporeal Membrane oxygenation","pediatric acute respiratory distress syndrome","prone position ventilation","2024-06-07",{"date":195,"type":196},"2024-06-10","ACTUAL",{"date":198,"type":196},"2024-05-09",{"date":200,"type":181},"2025-07-01",{"name":5,"class":6},8]