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

Nanjing Children's Hospital

Status: Active, not recruiting

Conditions: Pierre Robin Sequence (PRS); Airway Management; Difficult Laryngoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT07257276

NanjingCH-PRS-2025

FYX202360 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

294 participants in 2 patient groups

Easy Laryngoscopy Group

Description:

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

Description:

Infants with Pierre Robin sequence classified as Cormack-Lehane grade III-IV during direct laryngoscopy. This group represents patients with difficult laryngoscopic exposure.