3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence (PRS-3DCT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Airway Management; Difficult Laryngoscopy; Pierre Robin Sequence (PRS)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 294

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • anjing Children's Hospital, Affiliated with Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study included infants diagnosed with Pierre Robin sequence who underwent mandibular distraction osteogenesis under general anesthesia at Nanjing Children's Hospital between January 2023 and December 2025. All participants had complete preoperative 3D-CT imaging and intraoperative laryngoscopic grading records.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Easy Laryngoscopy Group; Infants with Pierre Robin sequence classified as Cormack-Lehane grade I-II during direct laryngoscopy. This group represents patients with easy laryngoscopic exposure.
Difficult Laryngoscopy Group; Infants with Pierre Robin sequence classified as Cormack-Lehane grade III-IV during direct laryngoscopy. This group represents patients with difficult laryngoscopic exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopy	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.	From preoperative imaging (3D-CT) to intraoperative laryngoscopic exposure

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Infants; Prediction Model; Difficult Airway; Quantitative Imaging; Pierre Robin Sequence; 3D-CT
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pierre Robin Syndrome
• Other Study ID Numbers: NanjingCH-PRS-2025; FYX202360 (Other Identifier: Jiangsu Maternal and Child Health Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a retrospective study involving patient privacy-sensitive information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No