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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-3
SponsorMarmara University Pendik Training and Research Hospital

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

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations