Anthropometric and US-Guided Difficult Intubation Prediction With ML Models

NCT ID: NCT06904586

Last Updated: 2025-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The assessment and management of difficult airway is of critical importance. Unsuccessful airway management leads to serious mortality and morbidity. From the beginning of the pre-anesthesia examination, 3% to 13% of patients who are considered suitable for routine airway management may be difficult to intubate. Airway assessment issues include risk assessment and airway examination (bedside and forward) to estimate the risk of difficult airway or aspiration. Airway examination aims to determine the presence of upper airway pathologies or anatomical anomalies. Some physical characteristics are associated with difficult airways and unsuccessful intubation. Examples of these are; limited neck movement, snoring, short sternomental distance, neck circumference thickness, etc. Physical characteristics can be measured with a meter or more detailed upper airway ultrasonographic measurements. In this study, researchers aimed to evaluate the anthropometric and ultrasonographic measurement values of patients who underwent preoperative airway assessment and to see the predictability of difficult intubation with artificial intelligence-supported decision support programs.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Difficult intubation, particularly unpredictable difficult intubation, is a challenging scenario for every anesthesiologist. Patients who are initially assessed as suitable for routine airway management may present as difficult to intubate in 5% to 22% of cases. Accurate evaluation and management of difficult airways are crucial, as failure in airway management can lead to serious morbidity and mortality.

Airway assessment helps identify predictable difficult airways, but it does not exclude patients with normal clinical evaluations who may still experience unpredictable difficult intubation. The primary goal of airway examination is to detect upper airway pathologies or anatomical anomalies. Several physical characteristics are associated with difficult airways and failed intubation, including limited neck mobility, snoring, a short sternomental distance, and increased neck circumference.

Common airway assessment tools, such as the Mallampati classification and the upper lip bite test, require patient cooperation, which limits their applicability in sedated, trauma, or unresponsive patients. The Cormack-Lehane classification, used during direct laryngoscopy, is invasive and does not allow for pre-procedural preparation. In this context, non-invasive, bedside, rapid, and accessible ultrasonographic assessments and anthropometric measurements have gained importance in predicting difficult airways.

With technological advancements, decision-support systems and artificial intelligence (AI)-assisted applications are increasingly used to prevent adverse outcomes. Successful airway management is particularly critical in high-risk patients, where rapid decision-making is essential. Easily accessible, bedside, non-invasive ultrasonographic measurements, integrated with AI-based learning programs, have the potential to predict difficult intubation in advance. This enables early preparation, timely interventions, and the reduction of life-threatening risks.

In this study, researchers aimed to predict difficult intubation preoperatively using non-invasive anthropometric and ultrasonographic upper airway measurements, combined with AI-assisted decision-support programs, without requiring any invasive procedures.

Our hypothesis is that preoperative airway assessment through anthropometric and ultrasonographic measurements, supported by AI-based decision-support programs, can accurately predict difficult intubation and facilitate early preparation

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Difficult Endotracheal Intubation Artificial Intelligence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients between the ages of 18 and 20 who will receive general anesthesia

ASA I-III patients over the age of 18 who meet the inclusion criteria to undergo general anesthesia

Thyromental distance

Intervention Type OTHER

Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position

Neck circumference

Intervention Type OTHER

Measurement of neck circumference with a tape measure when the patient is in a neutral position

Mouth opening distance

Intervention Type OTHER

Distance between the upper and lower teeth at the point where the mouth opening is maximum when the patient is in a neutral position.

Distance from jawbone to hyoid bone with neck in neutral position

Intervention Type OTHER

Distance from mentum to hyoid bone with neck in neutral position by ultrasonography

Distance from jawbone to hyoid bone with neck in extension

Intervention Type OTHER

Ultrasound measurement of distance from mentum to hyoid bone with neck in extension

Distance between skin and trachea

Intervention Type OTHER

Ultrasound measurement of distance between skin and trachea

Distance between skin and epiglottis

Intervention Type OTHER

Distance between skin and epiglottis measured by ultrasonography

Distance between skin and anterior commissure of vocal cord:

Intervention Type OTHER

Distance between skin and anterior commissure of vocal cord measured by ultrasonography

Distance between skin and hyoid bone

Intervention Type OTHER

Distance between skin and hyoid bone measured by ultrasonography

Maximum Tongue Thickness

Intervention Type OTHER

Measurement of Maximal Tongue Thickness by Ultrasonography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thyromental distance

Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position

Intervention Type OTHER

Neck circumference

Measurement of neck circumference with a tape measure when the patient is in a neutral position

Intervention Type OTHER

Mouth opening distance

Distance between the upper and lower teeth at the point where the mouth opening is maximum when the patient is in a neutral position.

Intervention Type OTHER

Distance from jawbone to hyoid bone with neck in neutral position

Distance from mentum to hyoid bone with neck in neutral position by ultrasonography

Intervention Type OTHER

Distance from jawbone to hyoid bone with neck in extension

Ultrasound measurement of distance from mentum to hyoid bone with neck in extension

Intervention Type OTHER

Distance between skin and trachea

Ultrasound measurement of distance between skin and trachea

Intervention Type OTHER

Distance between skin and epiglottis

Distance between skin and epiglottis measured by ultrasonography

Intervention Type OTHER

Distance between skin and anterior commissure of vocal cord:

Distance between skin and anterior commissure of vocal cord measured by ultrasonography

Intervention Type OTHER

Distance between skin and hyoid bone

Distance between skin and hyoid bone measured by ultrasonography

Intervention Type OTHER

Maximum Tongue Thickness

Measurement of Maximal Tongue Thickness by Ultrasonography

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients over 18 years of age
* Patients who will undergo general anesthesia

Exclusion Criteria

* Pregnant women
* Those with congenital and/or acquired facial deformities
* Patients who have previously undergone upper neck airway surgery
* Patients with head and neck tumors
* Patients who will undergo thyroidectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duzce University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gizem Demir Şenoğlu

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gizem DEMIR SENOGLU

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duzce University

Düzce, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/65

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.