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临床试验/NCT04289597
NCT04289597已完成不适用

Evaluation of Difficult Airway in Obese Patients With Ultrasonography

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年8月20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
128
试验地点
1
主要终点
Difficult Mask Ventilation

研究概览

简要总结

As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.

详细描述

Patients with BMI> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. In the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, Mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction], presence of sleep apnea and STOP-BANG score will be recorded. In the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 Hz linear probe. The distance between the hyoid bone-skin (DSHB), the vocal cord anterior commissura-skin distance (DSAC), the minimum distance of the trachea to the skin at the level of the suprasternal notch (DST), the distance between the thyroid isthmus and the skin (DSI), and the distance between the epiglottis and the skin (DSE) will be measured and recorded. After standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with Han Scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation. Difficult laryngoscopy will be evaluated with Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy. Difficult intubation will also be evaluated with the number and duration of intubation attempts with the Macintosh blade. Tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. The duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.

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

入选标准

  • Patients planned to undergo general anesthesia for elective surgery
  • American Anesthesiology Association physical classification (ASA) status I-III
  • Body mass index (BMI) above 30

排除标准

  • Patients with neck mass
  • History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth
  • History of difficult intubation
  • Bearded patients
  • Pregnant women

结局指标

主要结局

Difficult Mask Ventilation

时间窗: ''1 minute'' (During anesthesia induction)

Difficult mask ventilation will be evaluated with Han scale \[(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask\] and grade 3-4 will be recorded as difficult mask ventilation.

次要结局

  • Difficult intubation(''1 minute'')
  • The duration of endotracheal intubation time(1 minute)
  • Difficult laryngoscopy(''1 minute'')

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meryem Onay

Specialist Doctor-Anesthesiologist

Eskisehir Osmangazi University

研究点 (1)

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