Clinical Trial

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

Study acronym: PRS-3DCT
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07257276
Lead Sponsor Nanjing Children's Hospital
Conditions Pierre Robin Sequence (PRS), Difficult Laryngoscopy, Airway Management
Enrollment 294 participants
Start Date 2023-01-01
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-02