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NCT07257276

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

Sponsor: Nanjing Children's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Days - 3 Months

Study Type

OBSERVATIONAL

Enrollment

294

Start Date

2023-01-01

Completion Date

2025-12-31

Last Updated

2025-12-02

Healthy Volunteers

No

Locations (1)

anjing Children's Hospital, Affiliated with Nanjing Medical University

Nanjing, Jiangsu, China