跳至主要内容
临床试验/NCT03547193
NCT03547193已完成不适用

Evaluation of Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy: a Prospective Trial

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年5月5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
300
试验地点
1
主要终点
median Distance Skin to Epiglottis (mDSE)

研究概览

简要总结

Background: Unpredictable laryngoscopic difficulty remains a dramatic challenge for anaesthesiologists. Ultrasound (US) based airway assessment has been recently proposed as a useful tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation.

The aim of this study is to determine the correlation between the sonographic measurements of anterior cervical soft tissues's thickness and Cormack-Lehane grade view at direct laryngoscopy in patients with normal clinical screening tests.

Design: Prospective, single blinded, observational study. Number of patients: 300 adult patients Methods: All patients are assessed before surgery to evaluate clinical evidence of difficult airways. Simultaneous ultrasound measures of the anterior cervical soft tissues are performed.

At induction of anaesthesia the laryngoscopic view is graded by a different anaesthetist, blinded to the ultrasound assessments.

Statistical analysis:

Receiver operating characteristic curves (ROC) are used to determine the "difficulty prediction capability" of each sonographic measurement and to assess the optimal cut-off scores To allow for comparisons between "restricted-difficult" airway and "easy" airway groups, a two-sided Student's t-test and Fisher's exact test is employed as appropriate. The results will be averaged (mean ± standard deviation SD) for each parameter for continuous data. Values of p < 0.05 are considered as statistically significant.

详细描述

Unpredictable laryngoscopic difficulty, especially if difficult ventilation occurs, during standard laryngoscopy, remains a dramatic challenge for anaesthesiologists. Accurate airway assessment should always be performed, but the common clinical screening tests have shown low sensitivity and specificity with a limited predictive value. Ultrasound (US) based airway assessment has been recently proposed as a useful, simple, bedside and non-invasive tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation and these are mostly limited on specific groups of patients.

The aim of this prospective, single blinded, observational study is to determine the correlation between two neck ultrasound measures assessed at the pre-operative visit and Cormack-Lehane grade view at direct laryngoscopy, assessed at the induction of anaesthesia 24 hours later.

METHODS: During the pre-operative visit (24 hours before surgery), clinical screening tests to predict a difficult airway are performed and the anterior cervical soft tissue's thickness is assesses.

The thickness of the anterior cervical soft tissues is measured at two levels, thyro-hyoid membrane (pre-epiglottis space) and vocal cords (laryngeal inlet), using a US probe 10-13-MHz linear transducer placed in the transverse plane with the patient's head in neutral position.

On each level the distance from the skin in the median axis in cm (mDSE = median distance skin to epiglottis; mVC = median distance skin to vocal cords) and the surrounding Area in cm2 (PEA = pre-epiglottis area; AVC = Area pre vocal cords) are measured.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing pre-operative evaluation for elective surgery

排除标准

  • Predicted difficult intubation

结局指标

主要结局

median Distance Skin to Epiglottis (mDSE)

时间窗: 24 hours

The median Distance Skin to Epiglottis, unit of measure cm, is detected using a US linear probe (10-13-MHz) with the transducer placed in the transverse plane and the patient's head in neutral position. It represents the distance from the skin in the median axis and the epiglottis

次要结局

未报告次要终点

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abele Donati, MD

Study Director

Università Politecnica delle Marche

研究点 (1)

Loading locations...

相似试验