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Enrolling by invitation NCT07243106

Airway Ultrasound vs Clinical Predictors for Difficult Airway

Observational Ultrasonography Difficult Airway Preoperative Evaluation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ultrasonography, Difficult Airway, Preoperative Evaluation. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Role of Airway Ultrasonography in Predicting Difficult Airway: Comparison of Clinical and Sonographic Parameters

Overview

This prospective observational study aims to evaluate the diagnostic value of airway ultrasonography in predicting difficult intubation in adult patients undergoing elective surgery under general anesthesia. Preoperative sonographic measurements of upper airway structures will be compared with conventional clinical airway assessment parameters such as the Mallampati score, thyromental distance, and sternomental distance. The study seeks to determine whether ultrasonographic measurements can serve as independent predictors of difficult airway and whether combining them with clinical parameters improves diagnostic accuracy. Additionally, the correlation between sonographic findings and the Intubation Difficulty Scale (IDS) will be analyzed to assess the potential clinical utility of airway ultrasound in preoperative airway evaluation.

Detailed description

Airway management is one of the most critical and potentially life-threatening procedures in anesthesiology practice. Difficult intubation may result in severe morbidity and mortality if not promptly and effectively managed. Therefore, reliable preoperative prediction of a difficult airway is crucial for ensuring patient safety and optimizing perioperative outcomes.

Traditional clinical assessment methods-such as the Mallampati classification, thyromental distance, and sternomental distance-are commonly used to predict difficult airway. However, these predictors have limited sensitivity and specificity, and their diagnostic accuracy may vary depending on operator experience and subjective interpretation.

In recent years, ultrasonography has gained increasing acceptance in anesthesiology as a non-invasive, rapid, inexpensive, and real-time imaging technique. Airway ultrasonography enables direct visualization of individual anatomical variations in the upper airway, providing more objective and reproducible data for airway assessment.

The primary objective of this study is to determine the diagnostic performance of ultrasonographic parameters obtained from preoperative airway ultrasound in predicting difficult laryngoscopy and intubation, and to compare them with conventional clinical assessment methods. The study will also evaluate whether ultrasonographic measurements are independent predictors of difficult airway and whether combining sonographic and clinical parameters enhances overall diagnostic accuracy.

Furthermore, the relationship between ultrasound-based anatomical measurements and the Intubation Difficulty Scale (IDS) will be analyzed. This correlation aims to demonstrate the potential contribution of airway ultrasonography to clinical decision-making and its possible role in improving airway safety in anesthetic practice.

Hypotheses:

H0 (Null Hypothesis): Airway ultrasonography does not provide higher diagnostic accuracy than traditional clinical assessment methods in predicting difficult intubation and has no significant correlation with the Intubation Difficulty Scale (IDS).

H1 (Alternative Hypothesis): Airway ultrasonography provides higher diagnostic accuracy than traditional clinical assessment methods in predicting difficult intubation and is significantly correlated with the Intubation Difficulty Scale (IDS).

Primary outcome measures

  • The Intubation Difficulty Scale (IDS) [Time frame: During tracheal intubation (approximately 1-3 minutes after induction of anesthesia)]
  • Difficulty of mask ventilation [Time frame: During 2-minute face mask ventilation after induction of anesthesia]

Eligibility criteria

Inclusion criteria

  • Adult patients aged 18-60 years
  • Scheduled for elective surgery
  • ASA (American Society of Anesthesiologists) physical status I, II, or III
  • Planned for endotracheal intubation under general anesthesia

Exclusion criteria

  • Patients requiring emergency surgery
  • Patients with a known history of difficult intubation
  • Patients with head or neck trauma
  • Patients with a history of previous head or neck surgery or head/neck malignancy
  • Pregnant patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Tokat Gaziosmanpasa University — Tokat Province

Identifiers

NCT: NCT07243106 · 25-MOBAEK-329

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗