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

NCT07651904 | Not Yet Recruiting

• 1 other identifier: mar anest
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cleft Palate; Cleft Lip; Laryngospasm; Bronchospasm; Airway Obstruction; Postoperative Complications; Difficult Intubation

Keywords

cleft lip; cleft palate; pediatric anesthesia; perioperative respiratory adverse events; Han mask ventilation score; micrognathia; intubation difficulty score

Outcome Measures

Primary Outcomes (1)

• 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

  first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.

Secondary Outcomes (7)

• Independent Predictors of PRAE - Odds Ratios

  first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.

• Intubation Difficulty Score (IDS)

  Intraoperative

• Han Mask Ventilation Score

  Intraoperative, at time of mask ventilation

• Minimum SpO₂ During Intubation

  Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.

• Minimum SpO₂ During Extubation

  Lowest pulse oximetry value recorded during and immediately after extubation.

Study Arms (1)

Cleft Lip and/or Palate Surgery Cohort

Pediatric patients aged 0-3 years undergoing elective cleft lip and/or palate repair under general anesthesia. All subjects are managed per routine anesthesia protocol. Perioperative airway events and predictive clinical variables are prospectively recorded from induction through PACU discharge.

Other: Standard General Anesthesia per Institutional Protocol

Interventions

Standard General Anesthesia per Institutional Protocol OTHER

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.

Cleft Lip and/or Palate Surgery Cohort

Eligibility Criteria

• Age: 0 Years - 3 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Pre-existing respiratory failure or active tracheostomy
• Emergency surgical procedures
• Inability to obtain parental/guardian consent

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Related Publications (7)

• Feyrer J, Irouschek A, Golditz T, Schmidt J, Lutz R, Kesting M, Moritz A. Airway Management in Children Undergoing Cleft Lip or Cleft Palate Surgery: An 8-Year Retrospective Analysis of 274 Cases. Paediatr Anaesth. 2025 Nov;35(11):925-933. doi: 10.1111/pan.70038. Epub 2025 Aug 16.

  PMID: 40817740 BACKGROUND

• Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.

  PMID: 15220820 BACKGROUND

• Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

  PMID: 9416711 BACKGROUND

• Somerville N, Fenlon S. Anaesthesia For Cleft Lip And Palate Surgery. Continuing Education İn Anaesthesia, Critical Care And Pain. 2005/06/01;5(3).

  BACKGROUND

• Tümer M, Ankay Yılbaş A, Soysal Kaya M, Karakoyak B, Kaya K, Canbay Ö, Et Al. Anesthetic Approach And Perioperative Complications İn Cleft Lip / Palate Surgery: A Single Center Retrospective Study. ERCIYES MEDICAL JOURNAL. 2022;44

  BACKGROUND

• Gupta N, Nagar K, Dixit P, Tiwari T, Srivastava VK, Singh PR. Airway Consideration İn Cleft Patients-Challenges And Approaches. Journal Of Cleft Lip Palate And Craniofacial Anomalies. Jan-Jun 2022;9(1).

  BACKGROUND

• Denning S, Ng E, Wong Riff KWY. Anaesthesia for cleft lip and palate surgery. BJA Educ. 2021 Oct;21(10):384-389. doi: 10.1016/j.bjae.2021.06.002. Epub 2021 Aug 25. No abstract available.

  PMID: 34567793 BACKGROUND

MeSH Terms

Conditions

Cleft Palate; Cleft Lip; Laryngismus; Bronchial Spasm; Airway Obstruction; Postoperative Complications; Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases; Vocal Cord Dysfunction; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Bronchial Diseases; Respiratory Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• dilara göçmen

  Marmara University Pendik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara Göçmen

CONTACT

+90 216 625 45 45; dilara.gocmen@marmara.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist prof

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 16, 2026
• Study Start: June 27, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06