3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pierre Robin Sequence (PRS) Airway Management Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Difficult Laryngoscopy Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Pierre Robin Syndrome Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

0 day–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

anjing Children's Hospital, Affiliated with Nanjing Medical University

Nanjing, Jiangsu, 210008, China

About this study

This retrospective cohort study includes infants diagnosed with Pierre Robin sequence (PRS) who underwent mandibular distraction osteogenesis at the Children's Hospital of Nanjing Medical University between January 2023 and September 2025. Preoperative three-dimensional computed tomography (3D-CT) scans will be used to measure quantitative airway parameters, including the oropharyngeal sagittal area (S2) and the distance from the tongue base to the posterior pharyngeal wall (D4).

According to Cormack-Lehane grades obtained during laryngoscopy, infants will be classified into easy (grades I-II) and difficult (grades III-IV) exposure groups. Logistic regression will be used to identify independent predictors of difficult laryngoscopy, and a dual-parameter model combining S2 and D4 will be developed. The model's discrimination, calibration, and clinical usefulness will be assessed by receiver operating characteristic (ROC) curve analysis, calibration plots, and decision curve analysis (DCA).

Internal validation will be performed using bootstrap resampling (1000 iterations), and temporal external validation will be conducted using an independent cohort from 2025. The goal of this study is to construct a simple, objective, and reproducible model that can improve preoperative airway risk evaluation and support anesthetic management in PRS infants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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.

Treatment and study plan

Primary outcomes

Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

A 3D-CT-Based Dual-parameter Model for Predicting Difficult Laryngoscopy in Infants With Pierre Robin Sequence: Internal and Temporal External Validation

Acronym: PRS-3DCT

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Dec 2, 2025
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed