[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568620":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":53,"studyPopulation":44,"armGroups":54,"interventions":65,"overallOfficials":69,"centralContacts":74,"locations":79,"responsibleParty":143,"collaborators":147,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":154,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":44,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":82,"whyStopped":44,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"First-attempt success rate","The primary study outcome is to evaluate the first attempt success rate of oral tracheal intubation without desaturation (\\\u003C 90%) and\u002For bradycardia (\\\u003C 100 bpm) with video laryngoscope with supplemental oxygen (apneic oxygenation) vs without supplemental oxygen in infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs","From randomization until up to 15 minutes",[14,17,20,24,28,32,35,38,41],{"measure":15,"description":16,"timeFrame":12},"Desaturation rate","Occurrence and duration of moderate and severe desaturation (SpO2 \\\u003C 90% and SpO2 \\\u003C 80%), with or without bradycardia, during intubation.",{"measure":18,"description":19,"timeFrame":12},"Overall number of intubation attempts","The overall number of intubation attempts.",{"measure":21,"description":22,"timeFrame":23},"Time to intubation","Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography).","From randomization until up to 5 minutes",{"measure":25,"description":26,"timeFrame":27},"Respiratory complications rate","Respiratory complications and complications of airway management within the first 24 hours, such as airway injury, cardiopulmonary resuscitation, bleeding, aspiration of gastric contents, post-extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded. Respiratory complications are defined as the need for re-intubation after being extubated, persistent stridor (even if oxygen is not required), respiratory failure, the occurrence of pneumothorax, or the need for any additional diagnostic examination following respiratory problems (i.e., bronchoscopy, radiology).","From randomization until up to 24 hours",{"measure":29,"description":30,"timeFrame":31},"First EtCO2 after successful intubation","Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation","From randomization until up to 10 minutes",{"measure":33,"description":34,"timeFrame":23},"Cormack-Lehane score","The Cormack-Lehane score, classified as 1, 2a, 2b, 3, or 4, recorded at each laryngoscopy attempt",{"measure":36,"description":37,"timeFrame":23},"The need for additional devices","The need for additional devices used at any step of intubation",{"measure":39,"description":40,"timeFrame":12},"Duration of severe desaturation","Duration of moderate and severe desaturation (SpO2 \\\u003C 80%), with or without bradycardia, during intubation",{"measure":42,"description":43,"timeFrame":23},"Percentage of Glottic Opening (POGO) score","Percentage of Glottic Opening (POGO) score recorded at each laryngoscopy attempt, ranging from 0% to 100%, with 100% indicating the best possible glottic view",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":50,"maskingDescription":44,"whoMasked":51},"SINGLE",[52],"PARTICIPANT","Eligible children will undergo preparation for intubation following the local Standard Operating Procedures (SOPs) of the pediatric anesthesia departments. Mandatory monitoring includes pulse oximetry (SpO2), heart rate (HR), and non-invasive blood pressure (NIBP).\n\nAnesthesia Induction:\n\nWhere feasible, all children enrolled in this protocol will be pre-oxygenated for one minute prior to induction of anesthesia using a face mask with FiO2 1.0 and a flow rate of 6-10 L\u002Fmin. Anesthesia induction for tracheal intubation will involve a combination of sedative or hypnotic drugs, opioids, and a non-depolarizing muscle relaxant.\n\nRequired Medications (per protocol):\n\nNeuromuscular Blocking Agent (NMBA): One of the following-Rocuronium 0.5-1 mg\u002Fkg, Cis-Atracurium 0.2-0.5 mg\u002Fkg, Atracurium 0.5 mg\u002Fkg, Vecuronium 0.1 mg\u002Fkg, Mivacurium 0.2-0.3 mg\u002Fkg, or Succinylcholine 2 mg\u002Fkg.\n\nHypnotic Agent: One or more of the following-Thiopentone 4-7 mg\u002Fkg, Ketamine 0.5-2 mg\u002Fkg, Propofol 1-4 mg\u002Fkg, Midazolam 0.5-1 mg\u002Fkg, or Sevoflurane up to 8%.\n\nOptional Medications: An opioid and\u002For anticholinergic may be administered at the anesthetist's discretion.\n\nPre-Intubation Preparation:\n\nFollowing induction of anesthesia and administration of an NMBA, bag-mask ventilation with FiO2 1.0 (flow rate of 6-10 L\u002Fmin) will be performed for 60 seconds until apnea occurs. To facilitate airway management, complete neuromuscular blockade will be confirmed using train-of-four (TOF) monitoring. Oxygen administration, laryngoscopy, and tracheal intubation will follow.\n\nIntubation Procedure:\n\nOxygen administration during intubation is mandatory for all participants and will be randomized as follows:\n\nApneic Oxygenation: Oxygen will be administered at 1 L\u002Fkg\u002Fmin via a conventional nasal cannula. Laryngoscopy and tracheal intubation will proceed following apneic oxygenation.\n\nStandard Care: No apneic oxygenation will be administered. After induction, laryngoscopy and tracheal intubation will proceed without additional oxygen support.\n\nTube Selection:\n\nFor premature neonates under 1 kg, an uncuffed tube with an internal diameter (ID) of 2.5 will be used.\n\nFor premature neonates and newborns between 1 kg and 3.0 kg, an uncuffed tube with ID 3.0 will be used.\n\nFor babies over 3.0 kg up to 8 months, a cuffed tube with ID 3.0 or an uncuffed tube with ID 3.5 will be used.\n\nFor infants aged 8 to 12 months, a cuffed tube with ID 3.5 or an uncuffed tube with ID 4.0 will be used.\n\nOxygen delivery will follow the assigned randomization group, either via conventional nasal cannula (apneic oxygenation) or standard care.\n\nLaryngoscope Blade Selection:\n\nFor children weighing less than 1 kg, a Miller or Macintosh blade, size No. 0, will be used. In cases of unexpected difficult intubation, the difficult airway algorithm will be applied. After an unsuccessful first intubation attempt with the assigned flow rate, clinical judgment will guide the intubating physician on whether to repeat the attempt with the same flow rate or to modify the flow rate, blade size, or type of laryngoscope. A maximum of four intubation attempts will be allowed, with the final attempt performed by the most experienced physician present. Additional tools, such as a stylet or bougie, may be used at any stage. If intubation remains unsuccessful, the difficult airway algorithm will be applied, and a supraglottic airway (SGA) device will be inserted.",[55,59],{"label":56,"type":57,"description":58,"interventionNames":44},"Standard of care","NO_INTERVENTION","Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation.",{"label":60,"type":61,"description":62,"interventionNames":63},"Apneic oxygenation","EXPERIMENTAL","1 L\u002Fkg\u002Fmin FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.",[64],"Procedure: Apneic oxygenation",[66],{"type":67,"name":60,"description":62,"armGroupLabels":68,"otherNames":44},"PROCEDURE",[60],[70],{"name":71,"affiliation":72,"role":73},"Vinicius C Quintao, MD, MSc, PhD","Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo","PRINCIPAL_INVESTIGATOR",[75],{"name":71,"role":76,"phone":77,"phoneExt":44,"email":78},"CONTACT","+ 55 11 97127-3950","vinicius.quintao@hc.fm.usp.br",[80,99,113,129],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Perth Children's Hospital","RECRUITING","Perth","Western Australia","6009","Australia","AU",{"type":89,"coordinates":90},"Point",[91,92],115.8614,-31.95224,{"lat":92,"lon":91},[95],{"name":96,"role":76,"phone":97,"phoneExt":44,"email":98},"Britta S von Ungern-Sternberg, MD, PhD","08 64564806","Britta.Regli-VonUngern@health.wa.gov.au",{"facility":100,"status":82,"city":101,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Hospital das Clinicas HCFMUSP","São Paulo","05403000","Brazil","BR",{"type":89,"coordinates":106},[107,108],-46.63611,-23.5475,{"lat":108,"lon":107},[111],{"name":71,"role":76,"phone":112,"phoneExt":44,"email":78},"+55 11 97127-3950",{"facility":114,"status":82,"city":115,"state":116,"zip":44,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"British Columbia Children's Hospital","Vancouver","British Columbia","Canada","CA",{"type":89,"coordinates":120},[121,122],-123.11934,49.24966,{"lat":122,"lon":121},[125],{"name":126,"role":76,"phone":127,"phoneExt":44,"email":128},"Simon Whyte, MD","604-875-2711","swhyte@bcchr.ca",{"facility":130,"status":82,"city":131,"state":44,"zip":44,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Uppsala University Hospital","Uppsala","Sweden","SE",{"type":89,"coordinates":135},[136,137],17.63889,59.85882,{"lat":137,"lon":136},[140],{"name":141,"role":76,"phone":44,"phoneExt":44,"email":142},"Peter Frykholm, MD","peter.frykholm@uu.se",{"type":144,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Vinícius C Quintão, MD, MSc, PhD","Assistant Professor",[148,150],{"name":149,"class":6},"University of Bern",{"name":151,"class":6},"The University of Western Australia","100568620","sealion-study-on-supplemental-oxygenation-via-nasal-cannula-for-young-children-during-intubation-100568620",false,"NCT06683599","SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation","SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula","SEALION","Inclusion Criteria:\n\n* Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.\n* Neonates and infants up to 52 weeks post-conceptual age.\n* Written informed consent provided by legal guardians prior to the intervention.\n\nExclusion Criteria:\n\n* Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.\n* Requirement for an alternative technique to direct laryngoscopy to secure the airway.\n* Specific conditions, such as congenital heart disease requiring FiO₂ \\\u003C 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.","ALL","1 Minute","52 Weeks",{"count":164,"type":165},240,"ESTIMATED","INTERVENTIONAL",[168],"NA","Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \\\u003C80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L\u002Fkg\u002Fmin) can extend safe apnea time.\n\nThis study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.",[171,172,173],"Difficult Airway","Difficult Airway Intubation","Neonate",[175,60,173],"Difficult intubation","2026-08-24",{"date":178,"type":179},"2026-08-25","ACTUAL",{"date":181,"type":179},"2024-12-10",{"date":183,"type":165},"2027-12-01",{"name":145,"class":6},4]