[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642485":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":55,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"Marmara University Pendik Training and Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cleft Lip and\u002For Palate Surgery Cohort",null,"Pediatric patients aged 0-3 years undergoing elective cleft lip and\u002For palate repair under general anesthesia. All subjects are managed per routine anesthesia protocol. Perioperative airway events and predictive clinical variables are prospectively recorded from induction through PACU discharge.",[13],"Other: Standard General Anesthesia per Institutional Protocol",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Standard General Anesthesia per Institutional Protocol","No interventions beyond routine clinical anesthesia practice. All airway management decisions, including induction technique, laryngoscopy device selection, and extubation strategy, are made at the discretion of the attending anesthesiologist. Observational data collection only.",[9],[20],{"name":21,"affiliation":5,"role":22},"dilara göçmen","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Dilara Göçmen","CONTACT","+90 216 625 45 45","dilara.gocmen@marmara.edu.tr",{"type":22,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"dilara gocmen","assist prof","100642485","perioperative-respiratory-adverse-events-in-cleft-lip-and-palate-surgery-incidence-risk-factors-and-clinical-scoring-100642485",false,"NCT07651904","Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring","Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores","Inclusion Criteria:\n\n* Age 0-3 years (infants and toddlers)\n* Scheduled for elective cleft lip and\u002For palate repair surgery\n* General anesthesia planned\n* Written parental\u002Fguardian informed consent obtained\n\nExclusion Criteria:\n\n* Pre-existing respiratory failure or active tracheostomy\n* Emergency surgical procedures\n* Inability to obtain parental\u002Fguardian consent","ALL","0 Years","3 Years",{"count":43,"type":44},150,"ESTIMATED","OBSERVATIONAL","Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.\n\nThis prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and\u002For palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.",[48,49,50,51,52,53,54],"Cleft Palate","Cleft Lip","Laryngospasm","Bronchospasm","Airway Obstruction","Postoperative Complications","Difficult Intubation",[56,57,58,59,60,61,62],"cleft lip","cleft palate","pediatric anesthesia","perioperative respiratory adverse events","Han mask ventilation score","micrognathia","intubation difficulty score","NOT_YET_RECRUITING","2026-06-13",{"date":66,"type":67},"2026-06-16","ACTUAL",{"date":69,"type":44},"2026-06-27",{"date":71,"type":44},"2027-12-30",{"name":5,"class":6}]