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NOT YET RECRUITING
NCT07651904

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

Sponsor: Marmara University Pendik Training and Research Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

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.