跳至主要内容
临床试验/NCT05767099
NCT05767099招募中不适用

Ultrasound Parameters to Predict Difficult Videolaryngoscopy

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
1
主要终点
Distance from skin to Hyoid bone measured with lineal ultrasound probe

研究概览

简要总结

Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.

详细描述

The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.

Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.

Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).

Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).

The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues. But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

排除标准

  • Obesity class II defined as a BMI greater than
  • Pregnant.
  • Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
  • Abnormalities that condition anatomy alterations such as facial / cervical fractures.
  • Maxillofacial abnormalities
  • People who cannot give their consent

结局指标

主要结局

Distance from skin to Hyoid bone measured with lineal ultrasound probe

时间窗: 5 minutes

Tongue Thickness measured with convex probe

时间窗: 5 minutes

Distance from Jaw to Hyoid bone distance measured with convex probe

时间窗: 5 minutes

Distance from skin to epiglottis measured with lineal ultrasound probe

时间窗: 5 minutes

次要结局

  • Sternomental distance the distance from the suprasternal notch to the mentum and is measured with the head fully extended on the neck and the mouth closed(1minute)
  • Modified Mallampati Score Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible.(1minute)
  • neck circumference Using a flexible measuring tape in centimeters, neck circumference at the level of thethyroid cartilage will be measured(1minute)
  • Interincisor distance DIstance in centimeters between fornt incisors(1minute)
  • Upper Lip Bite Test upper lip bite criteria-class I = lower incisors can bite the upper lip above the vermilion line, class II = lower incisors can bite the upper lip below the vermilion line, and class III = lower incisors cannot bite the upper lip(1minute)
  • Thyromental distance measured from the thyroid notch to the tip of the jaw with the head extended(1minute)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (1)

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