[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560396":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":34,"responsibleParty":56,"collaborators":12,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":12,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard induction of anaesthesia in the child.","NO_INTERVENTION","Control group: in this group, standard induction of anaesthesia is performed without the use of apnoeic oxygenation.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental group: standard induction is supplemented by apnoeic oxygenation.","EXPERIMENTAL","In the experimental group, apnoeic oxygenation is used in addition to standard anaesthesia induction.",[18],"Other: apnoeic Oxygenation",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"apnoeic Oxygenation","One approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation. The principle is to deliver oxygen to the airways of anaesthetised patients via a conventional nasal cannula. As less carbon dioxide is produced than oxygen is consumed during apnoea, the supply of oxygen to the upper airways leads to an 'inward diffusion' of oxygen, which may prolongs the time until desaturation and hypoxaemia occur.",[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Davut Deniz Uzun, Dr. \u002FMD","CONTACT","+49 62215639349","deniz.uzun@med.uni-heidelberg.de",{"name":31,"role":27,"phone":32,"phoneExt":12,"email":33},"Felix Schmitt, Assoc. Professor.","+49 6221-56 394 21","Felix.Schmitt@med.uni-heidelberg.de",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,","RECRUITING","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],8.69079,49.40768,{"lat":47,"lon":46},[50,53],{"name":51,"role":27,"phone":52,"phoneExt":12,"email":29},"Davut Deniz Uzun, MD","0049 62215639349",{"name":54,"role":27,"phone":55,"phoneExt":12,"email":33},"Felix Schmitt, MD","0049 62215639421",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Dr. med. Davut Deniz Uzun","Resident Departement of Anesthesiology","100560396","apnoeic-oxygenation-during-pediatric-tracheal-intubation-100560396",false,"NCT06576596","Apnoeic Oxygenation During Pediatric Tracheal Intubation","Apnoeic Oxygenation During Pediatric Tracheal Intubation: a Study Protocol for a Single-center, Cluster Randomized Clinical Trial (ApOx-Pedi-Trial)","Inclusion Criteria:\n\n* children 0-6 years\n* ASA status I-III\n* Elective surgery\u002Fintervention under general anaesthesia\n\nExclusion Criteria:\n\n* refusal to participate in the study by the patients or their legal guardians\n* ASA classification IV = patients with life-threatening disease\n* Existing oxygen therapy prior to surgery\n* Surgery\u002Fintervention in the ENT area with contraindication for oxygen goggles\n* Injuries\u002Ftrauma in the ENT and mouth\u002Fnose area\n* Anatomical anomalies\u002Fmalformations in the ENT and mouth\u002Fnose area\n* Chronical hypoxemia (e.g. patients with cyanotic heart diseases)\n* language barrier (parent\u002Fguardian)\n* emergency interventions\n* refusal by the attending physician\n* lack of presence of the pediatric anesthesiology consultant\n* Situational inability to perform apnoeic oxygenation or inability to obtain baseline NIRS values at room air within 60 seconds from the first attempt due to agitation of the patient","ALL","0 Years","6 Years",{"count":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this randomized, controlled, single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia. The main question it aims to answer are:\n\nprimary outcome measure: The primary outcome will be the lowest SpO₂ value recorded during the apnoeic period.\n\nsecondary outcome measure:\n\n* Differences in intubation first-pass-success (key secondary objective)\n* Temporal differences to achieve successful intubation\n* Differences in time to oxygen desaturation\n* Differences in heart rate and mean arterial blood pressure decrease\n* Differences in the incidence of anesthesia-related adverse events\n\nThe study participants are randomized two age dependents groups. Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation.\n\nThe study population will be divided into two independent cohorts, each consisting of 100 patients. The first cohort, designated as \"infants\" will include all patients aged up to 24 months, while the second cohort, termed \"children\" will comprise patients aged older than 24 months and up to six years.\n\nWithin each cohort, patients will be randomized into an intervention group and a control group, with 50 patients assigned to each. This randomization will ensure that, for both the Infant and Children Groups, half of the participants (n=50) will receive the intervention, while the other half (n=50) will serve as controls.\n\nStatistical analysis of primary and secondary endpoints will be conducted independently for each cohort. This stratified approach will allow for targeted evaluation of age-specific effects of the intervention, as well as comparison between intervention and control outcomes within each age-defined cohort.",[78,79,80],"Anesthesia","Airway Complication of Anesthesia","Anesthesia; Adverse Effect",[82,83,84,85,86,87],"Airway Management","Pediatric Anesthesia","Apnoeic Oxygenation","Apneic Oxygenation","Oxygen","Tracheal Intubation","2025-02-26",{"date":90,"type":91},"2025-03-03","ACTUAL",{"date":93,"type":91},"2024-09-09",{"date":95,"type":72},"2025-08-31",{"name":5,"class":6},1]