An observational study in Cleft Palate, Cleft Lip and Laryngospasm, sponsored by Marmara University Pendik Training and Research Hospital. Not yet recruiting. Open to participants aged 0 Years to 3 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Marmara University Pendik Training and Research Hospital · Observational
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.
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.
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 150 is above the median of 85 across 40 observational studies indexed under Cleft Palate.
Browse Cleft Palate studies →Marmara University Pendik Training and Research Hospital is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Independent Predictors of PRAE - Odds Ratios
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).
Time frame: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Intubation Difficulty Score (IDS)
Composite intubation difficulty score (Adnet 1997) calculated as N1-N7 sum; IDS ≥5 defined as difficult intubation.
Time frame: Intraoperative
Han Mask Ventilation Score
Four-point scale assessing difficulty of mask ventilation; score ≥2 considered indicative of elevated PRAE risk.
Time frame: Intraoperative, at time of mask ventilation
Minimum SpO₂ During Intubation
Intraoperative
Time frame: Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.
Minimum SpO₂ During Extubation
At extubation
Time frame: Lowest pulse oximetry value recorded during and immediately after extubation.
Postoperative ICU Admission Rate
Proportion of patients requiring unplanned postoperative intensive care unit admission.
Time frame: Within 24 hours of surgery
Postoperative Hospital Length of Stay
Total duration of hospital stay in days.
Time frame: From surgery to hospital discharge, assessed up to 30 days
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jun 2026; primary completion for May 2027, 11 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Marmara University Pendik Training and Research Hospital