About this trial
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.
Eligibility criteria
Qualifiers
Age 0-3 years (infants and toddlers)
Scheduled for elective cleft lip and/or palate repair surgery
General anesthesia planned
Written parental/guardian informed consent obtained
Disqualifiers
Pre-existing respiratory failure or active tracheostomy
Emergency surgical procedures
Inability to obtain parental/guardian consent
Trial design
Treatments tested in this trial
- Standard General Anesthesia per Institutional Protocol