Clinical Trials Directory

Trials / Completed

CompletedNCT06904586

Anthropometric and US-Guided Difficult Intubation Prediction With ML Models

Evaluation of Anthropometric and Ultrasonographic Measurements With Different Machine Learning Methods in Predicting Difficult Intubation: A Prospective Observational Study

Status
Completed
Phase
Study type
Observational
Enrollment
329 (actual)
Sponsor
Duzce University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
OTHERThyromental distanceDistance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position
OTHERNeck circumferenceMeasurement of neck circumference with a tape measure when the patient is in a neutral position
OTHERMouth opening distanceDistance between the upper and lower teeth at the point where the mouth opening is maximum when the patient is in a neutral position.
OTHERDistance from jawbone to hyoid bone with neck in neutral positionDistance from mentum to hyoid bone with neck in neutral position by ultrasonography
OTHERDistance from jawbone to hyoid bone with neck in extensionUltrasound measurement of distance from mentum to hyoid bone with neck in extension
OTHERDistance between skin and tracheaUltrasound measurement of distance between skin and trachea
OTHERDistance between skin and epiglottisDistance between skin and epiglottis measured by ultrasonography
OTHERDistance between skin and anterior commissure of vocal cord:Distance between skin and anterior commissure of vocal cord measured by ultrasonography
OTHERDistance between skin and hyoid boneDistance between skin and hyoid bone measured by ultrasonography
OTHERMaximum Tongue ThicknessMeasurement of Maximal Tongue Thickness by Ultrasonography

Timeline

Start date
2024-03-01
Primary completion
2024-12-03
Completion
2025-01-31
First posted
2025-04-01
Last updated
2025-05-31
Results posted
2025-05-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06904586. Inclusion in this directory is not an endorsement.