- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06904586
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
Study Overview
Status
Intervention / Treatment
- Other: Thyromental distance
- Other: Neck circumference
- Other: Mouth opening distance
- Other: Distance from jawbone to hyoid bone with neck in neutral position
- Other: Distance from jawbone to hyoid bone with neck in extension
- Other: Distance between skin and trachea
- Other: Distance between skin and epiglottis
- Other: Distance between skin and anterior commissure of vocal cord:
- Other: Distance between skin and hyoid bone
- Other: Maximum Tongue Thickness
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Duzce, Turkey
- Duzce University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Distance between the chin and thyroid cartilage with a tape measure when the patient is in a neutral position
Measurement of neck circumference with a tape measure when the patient is in a neutral position
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 mentum to hyoid bone with neck in neutral position by ultrasonography
Ultrasound measurement of distance from mentum to hyoid bone with neck in extension
Ultrasound measurement of distance between skin and trachea
Distance between skin and epiglottis measured by ultrasonography
Distance between skin and anterior commissure of vocal cord measured by ultrasonography
Distance between skin and hyoid bone measured by ultrasonography
Measurement of Maximal Tongue Thickness by Ultrasonography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Support Vector Machine Algorithm Percentage of Accuracy in Predicted Difficult Intubations
Time Frame: 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.
|
Taking ultrasonographic and anthropometric measurements of each patient took approximately 20 minutes. Machine learning estimates for each patient are approximately 1 min.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gizem DEMIR SENOGLU, Duzce University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Artificial Intelligence
-
Uşak UniversityCompletedDigital Competences | Artificial Intelligence (AI) | Physiotherapist Students | Acceptance of Artificial Intelligence | Artificial Intelligence AttitudeTurkey
-
University of YalovaNot yet recruitingArtificial Intelligence | Nursing Education | Clinical Competence | Artificial Intelligence (AI) | Nursing Process | Nursing Process Competence | Artificial Intelligence Perception and AttitudeTurkey (Türkiye)
-
Cambridge Health AllianceEnrolling by invitationAI (Artificial Intelligence) | Large Language Model | Generative Artificial IntelligenceUnited States
-
John J ChenCompletedCommunication | Interdisciplinary Communication | Artificial Intelligence (AI) | Artificial Intelligence TechnologyUnited States
-
Radboud University Medical CenterPrime Dental Alliance EindhovenNot yet recruitingArtificial Intelligence Supported Image Reviewing | Artificial Intelligence (AI) in DiagnosisNetherlands
-
Tanta UniversityNot yet recruitingArtificial Intelligence
-
Recep Tayyip Erdogan UniversityCompleted
-
Istituto Clinico HumanitasCompletedArtificial IntelligenceItaly
-
Istituto Clinico HumanitasCompletedArtificial IntelligenceItaly
-
Second Affiliated Hospital, School of Medicine,...UnknownArtificial IntelligenceChina
Clinical Trials on Thyromental distance
-
Cairo UniversityUnknownDifficult Intubation
-
Diskapi Yildirim Beyazit Education and Research...RecruitingAirway Complication of AnesthesiaTurkey
-
Mayo ClinicCompletedMultiple Myeloma | Autologous Stem Cell TransplantUnited States
-
London School of Economics and Political ScienceUniversity of Witwatersrand, South AfricaCompletedHealth, Subjective | Health Knowledge, Attitudes, Practice | Health Care UtilizationSouth Africa
-
Medical University of ViennaRecruitingEndovenous Laser Ablation | Great Saphenous Vein IncompetenceAustria
-
Eskisehir Osmangazi UniversityCompleted
-
Asia UniversityHualien Tzu Chi General HospitalNot yet recruiting
-
IWK Health CentreCanadian Institutes of Health Research (CIHR); University of New BrunswickCompletedPost Traumatic Stress Disorder | Post Traumatic Stress InjuryCanada
-
California Pacific Medical Center Research InstituteNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Beijing Airdoc Technology Co., Ltd.Recruiting