NCT06982144

Brief Summary

Difficult airway is a life-threatening event during anesthesia. Prediction model is helpful to detect high-risk patients and decrease the risk of un-anticipated difficult airway. Present models are usually based on Mallampati grade and the width of mouth open. However, the prediction accuracy is only about 0.7-0.8 in different populations. Present study is designed to investigate if AI-based prediction model using medical imaging parameters (such as CT and MRI) can increase the accuracy of prediction model.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025May 2026

First Submitted

Initial submission to the registry

May 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

May 13, 2025

Last Update Submit

May 20, 2025

Conditions

Keywords

difficult airwayAI-based methodmedical imagingprediction model

Outcome Measures

Primary Outcomes (1)

  • The accuracy of prediction model based on AI analysis of medical imaging parameters

    To establish a prediction model for difficult tracheal intubation based on medical imaging parameters (such as CT and MRI) using AI algorithms and verify its predictive accuracy.

    day 1 (From enrollment to the end of anesthesia induction)

Study Arms (1)

Adult patients scheduled for selective surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with head and neck CT data undergoing surgery under general anesthesia with endotracheal intubation

You may qualify if:

  • age ≥18 years old;
  • surgical patients undergoing general anesthesia with endotracheal intubation;
  • with head and neck CT examination results
  • Consent to participate in the study.

You may not qualify if:

  • The presence of laryngeal edema;
  • The presence of airway stenosis, including internal airway stenosis (such as foreign body or tumor) or stenosis caused by external tracheal mass compression;
  • tracheo-esophageal fistula;
  • severe gastroesophageal reflux;
  • previous upper airway surgery, such as laryngeal cancer radical surgery, snoring surgery, etc.
  • )participating in other research projects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Central Study Contacts

Dongliang Mu Associate professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

May 20, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations