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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07257276
Acronym
PRS-3DCT
Enrollment
294
Registered
2025-12-02
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Nanjing Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 3 Months
Healthy volunteers
No

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). \-

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive performance of the 3D-CT-based dual-parameter model for difficult laryngoscopyFrom preoperative imaging (3D-CT) to intraoperative laryngoscopic exposureThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026