Perioperative Respiratory Adverse Events in Cleft Lip and Palate Surgery: Incidence, Risk Factors, and Clinical Scoring

Cleft lip and palate are among the most common congenital craniofacial anomalies.

The surgical population predominantly consists of infants and young children who may present with associated syndromes, micrognathia, retrognathia, or obstructive sleep apnea - all of which contribute to difficult mask ventilation and difficult intubation. Sharing the airway with the surgical team and the use of the Dingman retractor further increase the risk of airway compromise during emergence and extubation. Published data on PRAE incidence in this population are largely retrospective and heterogeneous, and no adequately powered prospective study has systematically evaluated predictive risk factors using validated scoring systems.

Study Design:

Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital, Istanbul, Turkey. No interventions beyond established routine anesthesia protocols will be performed. Parental written informed consent will be obtained prior to enrollment.

Anesthetic Protocol:

All patients will undergo standard intraoperative monitoring (ECG, non-invasive blood pressure, pulse oximetry, end-tidal CO₂). Anesthesia will be induced with sevoflurane inhalation followed by intravenous induction after vascular access. Maintenance will be achieved with sevoflurane and remifentanil infusion. Analgesia and perioperative steroid administration will follow the department's routine protocol.

Data Collection:

Preoperative variables: age, weight, cleft type (unilateral/bilateral/isolated lip/isolated palate/combined), cleft width and depth, alveolar gap, micrognathia, retrognathia, cervical extension limitation, OSAS history, Pierre Robin sequence, and prior ICU admission.

Intraoperative variables: induction type and agents, neuromuscular blockade use, operator experience level, mask ventilation difficulty (Han Score), number of intubation attempts, laryngoscopy device used, Cormack-Lehane grade, VIDIAC score, IDS score, adjunct airway tools employed, minimum SpO₂ and bradycardia during intubation, Dingman retractor duration, and steroid use.

Primary outcome assessment: extubation-related minimum SpO₂, laryngospasm, bronchospasm, post-extubation stridor, coughing episodes, and need for unplanned re-intubation or ICU admission.

Vital signs (heart rate, SpO₂, blood pressure) will be recorded at intubation, 15, 30, 60, 90, 120 minutes intraoperatively, and postoperatively.

Statistical Analysis:

Descriptive statistics will be reported as mean ± SD or median (IQR) for continuous variables and as n (%) for categorical variables. Univariate comparisons between PRAE and non-PRAE groups will employ independent samples t-test, Mann-Whitney U test, chi-square, or Fisher's exact test as appropriate. Independent predictors of PRAE will be identified via binary logistic regression (backward stepwise method), reported as odds ratios (OR) with 95% confidence intervals. Statistical significance threshold: p\<0.05.

Sample Size:

Based on a reported PRAE incidence of \~25% in comparable populations, a minimum of 120 patients is required (α=0.05, power=80%, G\*Power 3.1). Accounting for anticipated dropout and exclusions, the target enrollment is 140-150 patients.

• Independent Predictors of PRAE - Odds Ratios [Срок оценки: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.]
• Intubation Difficulty Score (IDS) [Срок оценки: Intraoperative]
• Han Mask Ventilation Score [Срок оценки: Intraoperative, at time of mask ventilation]
• Minimum SpO₂ During Intubation [Срок оценки: Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.]
• Minimum SpO₂ During Extubation [Срок оценки: Lowest pulse oximetry value recorded during and immediately after extubation.]
• Postoperative ICU Admission Rate [Срок оценки: Within 24 hours of surgery]
• Postoperative Hospital Length of Stay [Срок оценки: From surgery to hospital discharge, assessed up to 30 days]