Trial Outcomes & Findings for Anthropometric and US-Guided Difficult Intubation Prediction With ML Models (NCT NCT06904586)

NCT ID: NCT06904586

Last Updated: 2025-05-31

Results Overview

The dataset, labeled based on expert assessment of difficult intubation, was classified using eight widely accepted machine learning algorithms: logistic regression (LR) \[6\], support vector machine (SVM) \[7\], random forest (RF) \[8\], K-nearest neighbors (KNN) \[9\], Gaussian naive Bayes (GNB) \[10\], CatBoost \[11\], XGBoost \[12\], and decision tree (DT) \[13\]. From the original 30 parameters, the 15 most influential features were selected based on feature extraction methods and literature relevance. Preprocessing steps included handling missing values, with incomplete records excluded. The dataset was split into training (80%) and test (20%) sets. Models were trained on the training set, with hyperparameter tuning performed via 5-fold cross-validation to avoid overfitting. Final model performance was evaluated on the independent test set.

Recruitment status

COMPLETED

Target enrollment

329 participants

Primary outcome timeframe

Taking ultrasonographic and anthropometric measurements of each patient took approximately 20 minutes. Machine learning estimates for each patient are approximately 1 min.

Results posted on

2025-05-31

Participant Flow

Participant milestones

Participant milestones
Measure
Patients Between the Ages of 18 and 20 Who Will Receive General Anesthesia
Thyromental distance: Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position Neck circumference: Measurement of neck circumference with a tape measure when the patient is in a neutral position 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. Distance from jawbone to hyoid bone with neck in neutral position: Distance from mentum to hyoid bone with neck in neutral position by ultrasonography Distance from jawbone to hyoid bone with neck in extension: Ultrasound measurement of distance from mentum to hyoid bone with neck in extension Distance between skin and trachea: Ultrasound measurement of distance between skin and trachea Distance between skin and epiglottis: Distance between skin and epiglottis measured by ultrasonography Distance between skin and anterior commissure of vocal cord:: Distance between skin and anterior commissure of vocal cord measured by ultrasonography Distance between skin and hyoid bone: Distance between skin and hyoid bone measured by ultrasonography Maximum Tongue Thickness: Measurement of Maximal Tongue Thickness by Ultrasonography
Overall Study
STARTED
329
Overall Study
COMPLETED
329
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients Between the Ages of 18 and 20 Who Will Receive General Anesthesia
n=329 Participants
Thyromental distance: Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position Neck circumference: Measurement of neck circumference with a tape measure when the patient is in a neutral position 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. Distance from jawbone to hyoid bone with neck in neutral position: Distance from mentum to hyoid bone with neck in neutral position by ultrasonography Distance from jawbone to hyoid bone with neck in extension: Ultrasound measurement of distance from mentum to hyoid bone with neck in extension Distance between skin and trachea: Ultrasound measurement of distance between skin and trachea Distance between skin and epiglottis: Distance between skin and epiglottis measured by ultrasonography Distance between skin and anterior commissure of vocal cord:: Distance between skin and anterior commissure of vocal cord measured by ultrasonography Distance between skin and hyoid bone: Distance between skin and hyoid bone measured by ultrasonography Maximum Tongue Thickness: Measurement of Maximal Tongue Thickness by Ultrasonography
Age, Categorical
<=18 years
0 Participants
n=329 Participants
Age, Categorical
Between 18 and 65 years
317 Participants
n=329 Participants
Age, Categorical
>=65 years
12 Participants
n=329 Participants
Age, Continuous
45 years
STANDARD_DEVIATION 20 • n=329 Participants
Sex: Female, Male
Female
190 Participants
n=329 Participants
Sex: Female, Male
Male
139 Participants
n=329 Participants
Region of Enrollment
Turkey
329 Participants
n=329 Participants

PRIMARY outcome

Timeframe: Taking ultrasonographic and anthropometric measurements of each patient took approximately 20 minutes. Machine learning estimates for each patient are approximately 1 min.

The dataset, labeled based on expert assessment of difficult intubation, was classified using eight widely accepted machine learning algorithms: logistic regression (LR) \[6\], support vector machine (SVM) \[7\], random forest (RF) \[8\], K-nearest neighbors (KNN) \[9\], Gaussian naive Bayes (GNB) \[10\], CatBoost \[11\], XGBoost \[12\], and decision tree (DT) \[13\]. From the original 30 parameters, the 15 most influential features were selected based on feature extraction methods and literature relevance. Preprocessing steps included handling missing values, with incomplete records excluded. The dataset was split into training (80%) and test (20%) sets. Models were trained on the training set, with hyperparameter tuning performed via 5-fold cross-validation to avoid overfitting. Final model performance was evaluated on the independent test set.

Outcome measures

Outcome measures
Measure
Patients Between the Ages of 18 and 20 Who Will Receive General Anesthesia
n=329 Participants
Thyromental distance: Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position Neck circumference: Measurement of neck circumference with a tape measure when the patient is in a neutral position 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. Distance from jawbone to hyoid bone with neck in neutral position: Distance from mentum to hyoid bone with neck in neutral position by ultrasonography Distance from jawbone to hyoid bone with neck in extension: Ultrasound measurement of distance from mentum to hyoid bone with neck in extension Distance between skin and trachea: Ultrasound measurement of distance between skin and trachea Distance between skin and epiglottis: Distance between skin and epiglottis measured by ultrasonography Distance between skin and anterior commissure of vocal cord:: Distance between skin and anterior commissure of vocal cord measured by ultrasonography Distance between skin and hyoid bone: Distance between skin and hyoid bone measured by ultrasonography Maximum Tongue Thickness: Measurement of Maximal Tongue Thickness by Ultrasonography
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
support vector macine Accuracy
89.39 percentage of estimate
Interval 80.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
Logistic Regression Accuracy
77.27 percentage of estimate
Interval 70.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
Random Forest Accuracy
87.88 percentage of estimate
Interval 80.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
Decision Tree Accuracy
80.30 percentage of estimate
Interval 80.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
K-Nearest Neighbors Accuracy
74.24 percentage of estimate
Interval 70.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
Gaussian Naive Bayes Accuracy
71.21 percentage of estimate
Interval 70.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
CatBoost Accuracy
83.33 percentage of estimate
Interval 80.0 to 95.0
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
XGBoost Accuracy
81.82 percentage of estimate
Interval 80.0 to 95.0

Adverse Events

Patients Between the Ages of 18 and 20 Who Will Receive General Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant Professor

Duzce University

Phone: +905059313588

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place