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临床试验/NCT06611917
NCT06611917已完成不适用

Comparative Diagnostic Values of Physical Examination Tests and Ultrasonographic Measurements in Predicting Difficult Airways

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Effectiveness of Difficult Airway Prediction

研究概览

简要总结

This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.

详细描述

Anesthesiologists, intensive care specialists, and emergency physicians frequently encounter the challenge of managing difficult airways, a critical competency as failure to secure the airway can lead to severe consequences, including brain damage or death. Intubation, a complex procedure involving several anatomical maneuvers, has traditionally relied on physical examination indicators such as dental and facial anatomy, Mallampati score, and neck mobility to predict potential difficulties. However, these methods, while useful, often lack the accuracy needed for reliable prediction, leading to a significant percentage of unexpected difficult intubations.

Recent advances in medical imaging propose the use of radiological and ultrasonographic assessments to enhance predictive accuracy. Ultrasonography, in particular, offers a non-invasive, easily accessible method for examining airway structures, which could potentially transform standard practices in airway management. The American Society of Anesthesiologists recognizes the promising role of ultrasound in airway assessment, yet acknowledges the need for more standardized approaches to its implementation.

This research aims to compare the predictive value of physical examination findings with that of ultrasonographic measurements such as the distance from skin to hyoid bone, skin to epiglottis, and tongue volume. By establishing more reliable and sensitive ultrasonographic markers, this study seeks to provide clinicians with better tools for assessing the risk of difficult airways, ultimately contributing to safer anesthesia practices and reducing the incidence of intubation-related complications.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.
  • Individuals aged between 18 and 60 years.
  • Patients scheduled for elective surgery require endotracheal intubation under general anesthesia

排除标准

  • Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).
  • Individuals with active infections.
  • Those with cervical vertebral damage.
  • Patients with a history of head and neck trauma.
  • Individuals who have undergone previous head and neck surgery.
  • Patients with a history of head and neck radiotherapy.
  • Pregnant individuals.
  • Obese patients (body mass index > 30).
  • Non-cooperative patients.
  • Patients are requiring surgery under emergency conditions.

结局指标

主要结局

Effectiveness of Difficult Airway Prediction

时间窗: up to one hour

The primary outcome measures the effectiveness of ultrasonography and physical examination in predicting difficult airways in patients undergoing general anesthesia. Occurrence of a difficult airway is the primary outcome. A difficult airway is defined by specific clinical criteria: More than two intubation attempts, Intubation time exceeding 10 minutes, or Cormack-Lehane laryngoscopy grade of 3 or 4. Data will be collected during the intubation process. Intubation attempts and time will be recorded by the anesthesiologist, while the Cormack-Lehane grading will be assessed based on the view of the glottis during laryngoscopy. Measurement Process: Ultrasonographic measurements of the airway will be taken preoperatively using non-invasive ultrasound techniques. Additionally, physical examination tests will be performed preoperatively to assess airway risk. The outcome is categorized as difficult airway (yes/no) based on whether the patient meets any of the defined criteria.

次要结局

未报告次要终点

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Ezgi SUBASI

Specialist Doctor

Çanakkale Onsekiz Mart University

研究点 (1)

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