跳至主要内容
临床试验/NCT07306325
NCT07306325尚未招募不适用

Effectiveness of Ultrasonography in Evaluating the Airway and Predicting Difficult Intubation in Patients Diagnosed With Acromegaly

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 34 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
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Airway Ultrasonography

研究概览

简要总结

This is a prospective observational study.The purpose of this study is to predict difficult intubation with ultrasonographic evaluation combined with preoperative physical examination in patients diagnosed with acromegaly and planned for pituitary surgery.

详细描述

Airway management is an important issue for patient safety in anesthesia. Difficult ventilation and difficult intubation are important causes of anesthesia-related perioperative morbidity and mortality. It is reported that approximately 30% of anesthesia-related mortality is related to inadequacy in difficult airway management. The incidence of difficult intubation is 1.5-13.2% in the general population.

Features evaluated for difficult airway risk prediction: age, gender, body mass index, weight, height, history of difficult intubation, facial and jaw features, mouth opening, head and neck mobility, prominent upper incisors, presence of beard, upper lip bite test, mallampati score, thyromental distance, hyomental distance , sternomental distance includes the distance between the incisors.

Acromegaly is an endocrinological disease with significant mortality and morbidity due to high growth hormone (GH) and insulin-like growth factor-I (IGF-I) levels. It usually occurs due to a pituitary tumor. Excessive GH secretion in adults causes acromegaly with overgrowth in the acral areas. Acral changes seen in these patients may cause abnormal airway structure and, accordingly, airway management may become difficult during anesthesia. Typically, large nose and tongue, thick mandible, and thick and large lips can be observed in acromegaly. There is hypertrophy in the pharynx, larynx, tonsil, vocal cords, mucosa and soft tissues. These features of acromegaly may cause difficult mask ventilation and difficult intubation. The incidence of difficult intubation is observed to be 10%-30% in acromegalic individuals.

With developing technology, the use of ultrasonography in preoperative airway evaluation has become widespread. It is a real-time, non-invasive, easily accessible, mobile, safe, painless method that can be used to evaluate both the upper and lower airway. Clinical airway screening tests aim to predict difficult airways. Recent reviews have shown that ultrasonographic measurements have a greater predictive value than airway screening tests performed by physical examination. Measurements obtained from ultrasound include skin-vocal cord distance, skin-hyoid distance and skin-epiglotte distance.

In the preoperative physical examination; Age, gender, height, weight, body mass index, mouth opening, neck extension, mallampati score, thyromental-hyomental and sternomental distance, neck circumference measurement and upper lip bite test will be evaluated.

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

入选标准

  • • Patients diagnosed with acromegaly who are planned for endoscopic pituitary surgery
  • Volunteer participants
  • American Society of Anesthesiology - ASA 1, 2 and 3 patient groups
  • Patients with BMI<40

排除标准

  • ASA 4 patient group
  • History of previous neck surgery
  • Patients with a history of tracheostomy
  • Patients with a history of radiotherapy to the neck area
  • Patients with limited neck extension (rheumatological - traumatic reasons)
  • Patients with masses and lesions in the mouth and airway that may make intubation difficult.

结局指标

主要结局

Airway Ultrasonography

时间窗: one year

Sonoatomonic evaluation of the airway and determination of difficult intubation in participants diagnosed with acromegaly and planned for pituitary surgery. - Distance Between Skin-Vocal Cord Anterior Commissure (centimeters)

次要结局

  • preoperative physical examination(one year)
  • correlation with laboratory(one year)

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muzaffer GENCER

Associate Professor Doctor

Başakşehir Çam & Sakura City Hospital

研究点 (1)

Loading locations...

相似试验