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临床试验/NCT07383610
NCT07383610已完成不适用

Investigation of Ultrasonographic Predictors of Difficult Intubation and Difficult Mask Ventilation in Adult Patients

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Number of Participants with Difficult Intubation

研究概览

简要总结

Difficult airway management is a major cause of perioperative complications. Standard bedside airway assessment tests may have limited ability to predict difficult intubation and difficult mask ventilation. This prospective observational study aims to evaluate whether preoperative ultrasound measurements of airway structures (such as skin-to-epiglottis distance, tongue thickness, and pre-epiglottic space) can predict difficult intubation and difficult mask ventilation in adult patients undergoing surgery under general anesthesia.

详细描述

This prospective observational cohort study was conducted to evaluate the predictive value of preoperative ultrasonographic airway measurements for difficult intubation and difficult mask ventilation in adult patients undergoing elective surgery under general anesthesia. A total of 400 patients aged 18-70 years with ASA physical status I-III were included. Before induction of anesthesia, standard clinical airway assessment tests were recorded, and ultrasound measurements were performed to assess airway-related anatomical structures. Ultrasonographic parameters included skin-to-epiglottis distance, skin-to-thyroid cartilage distance, thyroid cartilage-to-epiglottis distance, pre-epiglottic space depth, tongue thickness, and hyomental distance measurements.

Intraoperatively, mask ventilation and intubation conditions were documented. Difficult intubation was defined as requiring two or more intubation attempts. Difficult mask ventilation was defined as the need for two-handed mask ventilation or inability to ventilate adequately using a face mask. The primary objective was to determine the association between ultrasonographic measurements and difficult intubation

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

入选标准

  • Age 18-70 years
  • ASA physical status I-III
  • Elective surgery under general anesthesia requiring orotracheal intubation
  • Written informed consent

排除标准

  • Refusal to participate
  • Emergency surgery
  • Known upper airway pathology or previous airway surgery
  • Restricted mouth opening (<3 cm)
  • Cervical spine instability or significant limitation of neck mobility
  • Morbid obesity (BMI ≥40 kg/m²)
  • Obstructive upper airway masses (e.g., head and neck tumors)
  • Prior neck radiotherapy
  • Clinically relevant neck masses
  • Major facial/mandibular trauma or craniofacial anomalies

研究组 & 干预措施

Cohort 1: Adult patients undergoing surgery under general anesthesia

Adult patients (18-70 years, ASA I-III) scheduled for elective surgery under general anesthesia requiring orotracheal intubation. Preoperative clinical airway assessment and ultrasonographic airway measurements were recorded, and intraoperative intubation and mask ventilation outcomes were evaluated

结局指标

主要结局

Number of Participants with Difficult Intubation

时间窗: During induction of anesthesia (intraoperative)

Difficult intubation was defined as requiring two or more intubation attempts (≥2 attempts) during induction of general anesthesia.

Number of Participants with Difficult Mask Ventilation

时间窗: During induction of anesthesia (intraoperative)

Difficult mask ventilation was defined as the need for two-handed mask ventilation or inability to ventilate adequately using a face mask

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan TELLİ

Principal Investigator

Kutahya Health Sciences University

研究点 (1)

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