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临床试验/NCT07243106
NCT07243106Enrolling By Invitation不适用

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

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
140
试验地点
1
主要终点
The Intubation Difficulty Scale (IDS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Adult patients scheduled for elective surgery under general anesthesia with endotracheal intubation

Demographic data of all participants-including age, sex, type of planned surgery, ASA physical status, and comorbidities-will be recorded. Before induction of anesthesia, all patients will be evaluated using standard clinical airway assessment parameters. These include the Mallampati score, thyromental distance, sternomental distance, neck circumference, and upper lip bite test. Body mass index (BMI) and waist-to-hip ratio will also be measured and documented.

In the preoperative period, all patients will undergo airway ultrasonography performed by an anesthesiologist. Sonographic assessments will be carried out by a single experienced anesthesiologist using a linear transducer, with the patient positioned in the sniffing position. The following ultrasound measurements will be obtained and recorded: Skin-to-epiglottis distance, skin-to-hyoid bone distance, skin-to-anterior commissure of the vocal cords distance, skin-to-trachea distance at the suprasternal notch level.

结局指标

主要结局

The Intubation Difficulty Scale (IDS)

时间窗: 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 ventilation

时间窗: During 2-minute face mask ventilation after induction of anesthesia

After 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

次要结局

未报告次要终点

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Genc

Assistant professor

Tokat Gaziosmanpasa University

研究点 (1)

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