A Prospective Observational Study Comparing the El Ganzouri Risk Index and Airway Ultrasonography in Predicting Difficult Intubation in Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Association between each individual ultrasound parameter and difficult laryngoscopy
研究概览
简要总结
This study is designed as a prospective observational study and will be conducted at the Health Sciences University Antalya Training and Research Hospital. Adult patients scheduled to undergo bariatric surgery will be included.
The aim of this study is to compare the El Ganzouri Risk Index (EGRI) and airway ultrasonography (USG) parameters in predicting difficult intubation and to evaluate their relationship with the Cormack-Lehane (CL) score obtained during direct laryngoscopy.
Before surgery, each participant will be evaluated using both the EGRI scoring system and airway USG. During general anesthesia, tracheal intubation will be performed using direct laryngoscopy, and data including the CL score, intubation time, number of attempts, and the need for videolaryngoscopy will be recorded based on the anesthesiologist's observations.
The collected data will be analyzed by classifying participants according to the presence or absence of difficult intubation, and statistical comparisons will be performed between EGRI scores and airway ultrasonography parameters. The results of this study may contribute to improved preoperative airway assessment and enhanced patient safety in bariatric surgery.
详细描述
Background and Rationale
Airway management is a fundamental aspect of anesthesia practice and plays a critical role in ensuring patient safety during surgical procedures. Under general anesthesia, suppression of spontaneous breathing necessitates the secure maintenance of airway patency. Successful tracheal intubation is essential for the safe conduct of surgery; however, in some patients, intubation may be unexpectedly difficult. According to current definitions, difficult intubation is characterized by the inability to adequately visualize glottic structures using standard techniques, resulting in failure or the need for multiple attempts. Delayed or failed intubation following anesthesia induction can lead to serious complications, including hypoxemia, aspiration, bradycardia, and cardiac arrest. Therefore, accurate preoperative prediction of difficult intubation is of critical importance. Early identification of difficult airway cases allows for timely implementation of alternative techniques and airway devices, thereby reducing perioperative risks and complications.
Obesity has emerged as a major global health concern and represents a significant risk factor for difficult intubation. Bariatric surgery is indicated in individuals with a body mass index (BMI) ≥40 kg/m² or ≥35 kg/m² in the presence of serious comorbidities, with the aim of reducing obesity-related metabolic, cardiovascular, and respiratory complications while improving quality of life. However, obese patients present unique challenges in airway management due to increased adipose tissue in the neck, reduced cervical-pharyngeal angles, and enlarged soft tissue structures. These anatomical factors impair visualization of laryngeal structures and may prolong intubation time, thereby increasing the risk of airway-related complications.
EGRI was developed as a comprehensive scoring system for predicting difficult intubation by incorporating multiple airway assessment parameters, including mouth opening, Mallampati classification, neck mobility, mandibular protrusion, upper incisors, thyromental distance, and a history of difficult intubation. Several studies have demonstrated the clinical utility and predictive value of EGRI in preoperative airway assessment.
Airway USG has recently gained attention as a non-invasive method for predicting difficult intubation. This technique enables real-time visualization of airway anatomy and allows measurement of parameters such as skin-to-epiglottis distance, skin-to-hyoid bone distance, skin-to-vocal cord distance, and tongue thickness. Previous studies suggest that USG may provide predictive accuracy comparable to or greater than that of traditional clinical indices, including EGRI. However, evidence regarding its use in patients undergoing bariatric surgery remains limited, underscoring the need for further investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 65 years.
- •ASA physical status classification II or III.
- •Scheduled to undergo elective bariatric surgery under general anesthesia.
- •Patients who voluntarily agree to participate in the study and sign the informed consent form.
排除标准
- •Patients younger than 18 years or older than 65 years
- •Presence of upper airway anatomical pathology
- •History of tracheal or thyroid surgery.
- •History of radiotherapy to the head and neck region.
- •Cervical spine anomalies.
- •Individuals unwilling to participate in the study.
结局指标
主要结局
Association between each individual ultrasound parameter and difficult laryngoscopy
时间窗: Baseline (preoperative period)
Difficult laryngoscopy will be defined as CL grades III-IV, which will serve as the reference standard. Each predefined airway ultrasonography parameter will be analyzed independently to evaluate its association with difficult laryngoscopy. No composite score will be calculated. The following preoperative airway ultrasonography measurements will be assessed individually: Tongue base thickness Hyomental distance in the neutral position Hyomental distance in the extended position Hyomental ratio (extension/neutral) Skin-to-hyoid distance Skin-to-epiglottis distance Skin-to-vocal cords (anterior commissure) distance Skin-to-cricoid cartilage distance Pre-epiglottic space depth Unit of Measure Centimeters (cm) for all linear measurements
次要结局
- Association Between Airway Ultrasonography Parameters and Intubation Performance(Perioperative period (during tracheal intubation))
- Comparison of Diagnostic Performance Between the EGRI and Airway USG Measurements(Baseline (preoperative period))
- Predictive Performance of the EGRI for Difficult Laryngoscopy(Baseline (preoperative period))
- Association Between Early Intraoperative Hemodynamic Instability and Difficult Laryngoscopy(Perioperative period (first 30 minutes of surgery))
- Incidence and Clinical Correlates of Difficult Laryngoscopy in Obese Adults Undergoing Bariatric Surgery(Perioperative period (during tracheal intubation))