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.
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
Pre-existing respiratory failure or active tracheostomy
Emergency surgical procedures
Inability to obtain parental/guardian consent
Infants and toddlers aged 0-3 years scheduled for elective cleft lip and/or palate repair under general anesthesia . No randomization is performed; all management follows routine institutional anesthesia practice.
Cohort
Retrospective
Standard General Anesthesia per Institutional Protocol
Other interventionNo 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.
Incidence of Perioperative Respiratory Adverse Events (PRAEs)
Composite outcome defined as the occurrence of at least one of the following: laryngospasm, bronchospasm, post-extubation stridor, oxygen desaturation lasting \>10 seconds (SpO₂ \<90%), or unplanned re-intubation, occurring at any point from induction through PACU discharge
Independent Predictors of PRAE - Odds Ratios
Identification of independent risk factors for PRAE via binary logistic regression, including Han Mask Ventilation Score, IDS, age, cleft type, micrognathia, retrognathia, OSAS, Pierre Robin sequence, and passive smoke exposure. Results reported as OR (95% CI).
Intubation Difficulty Score (IDS)
Composite intubation difficulty score (Adnet 1997) calculated as N1-N7 sum; IDS ≥5 defined as difficult intubation.
Han Mask Ventilation Score
Four-point scale assessing difficulty of mask ventilation; score ≥2 considered indicative of elevated PRAE risk.
Minimum SpO₂ During Intubation
Intraoperative
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