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

NCT07257276 | Active Not Recruiting

• 2 other identifiers: NanjingCH-PRS-2025FYX202360
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

3D-CT; Quantitative Imaging; Difficult Airway; Infants; Prediction Model; Pierre Robin Sequence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Undergoing mandibular distraction osteogenesis under general anesthesia.
• Complete preoperative 3D-CT imaging data available.
• Complete intraoperative laryngoscopic grading recorded (Cormack-Lehane classification).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

anjing Children's Hospital, Affiliated with Nanjing Medical University

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Pierre Robin Syndrome

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)