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Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring
Sponsor: Marmara University Pendik Training and Research Hospital
Summary
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. This prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and/or 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.
Official title: 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
Key Details
Gender
All
Age Range
0 Years - 3 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-06-27
Completion Date
2027-12-30
Last Updated
2026-06-16
Healthy Volunteers
Not specified
Conditions
Interventions
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.