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临床试验/NCT03013036
NCT03013036Unknown不适用

Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size

Istanbul University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance

研究概览

简要总结

Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.

详细描述

After ethics committee approval and parental consent were obtained, 119 patients undergoing genitourinary surgery or inguinal hernia repair under general anesthesia, were included in study. Patients with head or neck anomalies, syndromic patients, patients undergoing emergency surgery and patients with a history of difficult airway were excluded from the study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5 years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following sevoflurane induction in groups I and II. In group III, USG measurements were performed following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic and subglottic diameters were measured with ultrasonography. The size of the endotracheal tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5 mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration , Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of age related formula and Bae 's formula, only patients who were intubated with un-cuffed endotracheal tube were evaluated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 1 and 8 years
  • Elective surgery

排除标准

  • Patients with head or neck abnormalities
  • Syndromic patients
  • Emergency surgery and patients with a
  • History of difficult airway
  • Allergy to ultrasound gel

研究组 & 干预措施

Group I

Other

Patients between 1 and 2 years

干预措施: intravenous midazolam (Drug)

Group I

Other

Patients between 1 and 2 years

干预措施: Ultrasonography (Device)

Group I

Other

Patients between 1 and 2 years

干预措施: Sevoflurane (Drug)

Group I

Other

Patients between 1 and 2 years

干预措施: fentanyl and rocuronium (Drug)

Group II

Other

patients between 3 and 5 years

干预措施: Ultrasonography (Device)

Group II

Other

patients between 3 and 5 years

干预措施: Sevoflurane (Drug)

Group II

Other

patients between 3 and 5 years

干预措施: Propofol (Drug)

Group II

Other

patients between 3 and 5 years

干预措施: fentanyl and rocuronium (Drug)

Group III

Other

patients between 6 and 8 years

干预措施: Ultrasonography (Device)

Group III

Other

patients between 6 and 8 years

干预措施: Sevoflurane (Drug)

Group III

Other

patients between 6 and 8 years

干预措施: intravenous midazolam (Drug)

Group III

Other

patients between 6 and 8 years

干预措施: fentanyl and rocuronium (Drug)

结局指标

主要结局

Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance

时间窗: three years

Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter

时间窗: three years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Aybike Ozmumcu

Medical Doctor

Istanbul University

研究点 (1)

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