Pierre Robin Sequence (PRS)Difficult LaryngoscopyAirway Management
Study summary
This study aims to develop and validate a quantitative prediction model using three-dimensional computed tomography (3D-CT) imaging for identifying infants with Pierre Robin sequence (PRS) at risk of difficult laryngoscopy. A dual-parameter model incorporating the oropharyngeal sagittal area (S2) and the distance between the tongue base and the posterior pharyngeal wall (D4) will be established. Internal validation will be performed using data from PRS infants treated between 2023 and 2024, and temporal external validation will be conducted using an independent cohort from 2025.
This study seeks to provide an accurate, non-invasive tool for preoperative airway risk assessment in PRS infants, thereby improving anesthetic safety and clinical decision-making.
Eligibility
Sex
ALL
Min age
0 Days
Max age
3 Months
Healthy volunteers
No
Inclusion Criteria:Infants diagnosed with Pierre Robin sequence (PRS) based on mandibular hypoplasia, glossoptosis, and upper airway obstruction.
Undergoing mandibular distraction osteogenesis under general anesthesia.
Complete preoperative 3D-CT imaging data available.
Complete intraoperative laryngoscopic grading recorded (Cormack-Lehane classification).
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Exclusion Criteria:
* Presence of other craniofacial syndromes (e.g., Treacher Collins syndrome, Goldenhar syndrome).
Incomplete or poor-quality 3D-CT images.
Missing laryngoscopic grading or intraoperative data.
History of airway surgery before CT imaging.
Primary outcome measure(s)
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy — From preoperative imaging (3D-CT) to intraoperative laryngoscopic exposure The primary outcome is the discriminative ability of the 3D-CT-based dual-parameter model (including S2 and D4) to predict difficult laryngoscopy in infants with Pierre Robin sequence. Predictive performance will be assessed using area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and calibration analysis.
Trial sites (1)
Facility
City
Region
Status
anjing Children's Hospital, Affiliated with Nanjing Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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