[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460710":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"children","EXPERIMENTAL","Compression of adjacent vessels (jugular vein and carotid artery), near the left paratracheal area. The risk of compression of the vessels will be assessed before performing the maneuver.\n\nAt the screening time before the intervention, we will perfom an ultrasonography measurement while we applied the maneuver in order to eliminate a risk of compression of the vessels, defined as a reduction in diameter of 50%.",[13],"Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children","Pressure will be applied with two fingers in the area located between the trachea and the sternal head of the sternocleidomastoid muscle on the left side to compress the cervical esophagus.\n\nThe force applied (after measuring the equivalent force applied on a precision scale) will be about 10 - 15 N. This force will be adapted according to the child's body weight : 10 N below 20 kgs and 15 N between 20 kgs and 40 kgs",[9],null,[21,39],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique","RECRUITING","Lille","France","FR",{"type":28,"coordinates":29},"Point",[30,31],3.05512,50.63391,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Dina BERT, Dr","CONTACT","0320446269","dina.bert@chru-lille.fr",{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":40,"geoPoint":42,"contacts":43},{"type":28,"coordinates":41},[30,31],{"lat":31,"lon":30},[44],{"name":35,"role":36,"phone":45,"phoneExt":19,"email":38},"03 20 44 62 69",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100460710","mask-ventilation-with-paratracheal-pressure-in-children-para-tracheal-compression-to-prevent-gastric-insufflation-in-children-100460710",false,"NCT05279170","MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children","Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study","MAVEPPIC","Inclusion Criteria:\n\n* Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation\n* inhalation induction\n* elective surgery\n* ASA status 1 or 2\n* consent of the child if he\u002Fshe is able to express it\n* consent of both parents and\u002For legal guardians\n* socially insured\n\nExclusion Criteria:\n\n* Child under 2 years old or \\> 10 years\n* body weight is over 40 kgs\n* ASA status 3 or higher\n* Emergency surgery or unscheduled surgery\n* scheduled ENT or esogastric surgery\n* Achalasia of the esophagus or history of GERD pathology\n* History of esophageal surgery (NISSEN type)\n* BMI indexed to age and sex showing childhood obesity\n* Predictable mask ventilation difficulties\n* History of Tracheostomy\n* Child not insured by social security","ALL","2 Years","10 Years",{"count":60,"type":61},72,"ESTIMATED","INTERVENTIONAL",[64],"NA","The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of \"full stomach\" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects.\n\nA new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children",[67,68],"Surgery","Anesthesia Intubation Complication",[70,71,72,9,73,74],"Low Left Paratracheal esophagus Pressure","gastric insufflation","Echography","elective surgery","positive pressure ventilation","2025-12-18",{"date":77,"type":78},"2025-12-26","ACTUAL",{"date":80,"type":78},"2024-06-06",{"date":82,"type":61},"2027-06",{"name":5,"class":6},2]