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Airway Ultrasound vs Clinical Predictors for Difficult Airway

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07243106
Enrollment
140
Registered
2025-11-21
Start date
2025-12-20
Completion date
2026-09-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway, Preoperative Evaluation, Ultrasonography

Brief summary

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).

Interventions

None listed

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Intubation Difficulty Scale (IDS)During tracheal intubation (approximately 1-3 minutes after induction of anesthesia)The Intubation Difficulty Scale (IDS) is a quantitative scoring system used to objectively assess the complexity of tracheal intubation. It incorporates seven parameters: number of intubation attempts, number of operators, number of alternative techniques used, Cormack-Lehane grade, lifting force required, necessity of external laryngeal pressure, and position of the vocal cords. The total IDS score is calculated as the sum of these variables, providing a numerical indicator of intubation difficulty (IDS = 0 indicates easy intubation; IDS = 1-5 mild to moderate difficulty; IDS \> 5 difficult intubation).
Difficulty of mask ventilationDuring 2-minute face mask ventilation after induction of anesthesiaAfter standard induction of anesthesia, all patients will be ventilated via face mask for 2 minutes, followed by tracheal intubation using a Macintosh laryngoscope. The difficulty of mask ventilation will be assessed using the Han Mask Ventilation Scale, defined as follows: Class 1: Mask ventilation possible Class 2: Mask ventilation possible with the use of an oral airway or other adjuncts Class 3: Mask ventilation possible only with the assistance of a second person Class 4: Mask ventilation impossible

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026