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临床试验/NCT07309978
NCT07309978招募中不适用

Assessment Of Difficult Airway Predictors: A Prospective Comparison Of Upper Airway Ultrasound And Conventional Anthropometric Measures

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation

研究概览

简要总结

This prospective observational study aims to evaluate whether upper airway ultrasound measurements can improve the prediction of difficult airway compared with conventional anthropometric assessments. Adult patients undergoing elective procedures requiring airway management will be included. Ultrasound parameters such as tongue thickness, anterior neck soft tissue thickness, and hyomental distance will be measured before airway intervention. Standard clinical predictors (Mallampati score, thyromental distance, neck circumference, etc.) will also be recorded. The primary objective is to determine the diagnostic accuracy of ultrasound-based measurements in predicting difficult laryngoscopy and intubation. The study seeks to provide evidence supporting the integration of upper airway ultrasound into routine pre-anesthetic airway evaluation.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-99 years
  • Patients scheduled for elective surgery under general anesthesia
  • ASA Physical Status I-III
  • Able to provide informed consent
  • Undergoing preoperative airway evaluation

排除标准

  • - Emergency surgery cases
  • Age <18 years
  • ASA Physical Status IV-V
  • Pregnant or breastfeeding patients
  • Patients with limited cooperation or inability to provide consent
  • Known anatomical airway anomalies or previous major neck surgery

研究组 & 干预措施

Single Cohort

This cohort includes all adult participants undergoing airway evaluation with upper airway ultrasound and standard anthropometric measurements. No interventions are applied; participants are observed prospectively to assess the predictive value of ultrasound parameters for difficult airway.

结局指标

主要结局

Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation

时间窗: Preoperative assessment (within 1 hour before induction of anesthesia)

Evaluation of the sensitivity, specificity, and area under the ROC curve (AUC) of ultrasound-based airway measurements-tongue thickness, hyoid-to-skin distance, and epiglottis-to-skin distance-in predicting difficult mask ventilation. These ultrasound parameters will be compared with conventional anthropometric airway assessment tests to determine their predictive performance.

次要结局

未报告次要终点

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sami Eksert

anesthesiology specialist

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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