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

June 13, 2026 updated by: dilara gocmen, Marmara University Pendik Training and Research Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Perioperative Respiratory Adverse Events (PRAEs)
Time Frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent Predictors of PRAE - Odds Ratios
Time Frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
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).
first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Intubation Difficulty Score (IDS)
Time Frame: Intraoperative
Composite intubation difficulty score (Adnet 1997) calculated as N1-N7 sum; IDS ≥5 defined as difficult intubation.
Intraoperative
Han Mask Ventilation Score
Time Frame: Intraoperative, at time of mask ventilation
Four-point scale assessing difficulty of mask ventilation; score ≥2 considered indicative of elevated PRAE risk.
Intraoperative, at time of mask ventilation
Minimum SpO₂ During Intubation
Time Frame: Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.
Intraoperative
Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.
Minimum SpO₂ During Extubation
Time Frame: Lowest pulse oximetry value recorded during and immediately after extubation.
At extubation
Lowest pulse oximetry value recorded during and immediately after extubation.
Postoperative ICU Admission Rate
Time Frame: Within 24 hours of surgery
Proportion of patients requiring unplanned postoperative intensive care unit admission.
Within 24 hours of surgery
Postoperative Hospital Length of Stay
Time Frame: From surgery to hospital discharge, assessed up to 30 days
Total duration of hospital stay in days.
From surgery to hospital discharge, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University Pendik Training and Research Hospital

Investigators

  • Principal Investigator: dilara göçmen, Marmara University Pendik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 27, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 13, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mar anest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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