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临床试验/NCT07340346
NCT07340346已完成不适用

Evaluation of the Reliability of Preoperative Airway Assessment Tests in Predicting Difficult Airway Management in Obstetric Patients Undergoing Cesarean Section

Akdeniz University Hospital1 个研究点 分布在 1 个国家目标入组 546 人开始时间: 2023年8月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
546
试验地点
1
主要终点
Prediction of Difficult Airway Using Preoperative Airway Assessment Tests

研究概览

简要总结

This observational study (OB-DIFF-AIRWAY: Obstetric Difficult Airway Study) aimed to evaluate the accuracy of commonly used preoperative airway assessment tests in predicting difficult airway management in obstetric patients undergoing cesarean section. Difficult airway remained a significant cause of anesthesia-related complications, particularly in pregnant patients due to physiological and anatomical changes.

Adult pregnant women scheduled for elective or urgent cesarean section underwent standard preoperative airway assessment, including Mallampati classification, thyromental distance, interincisor distance, neck circumference, and other routine clinical evaluations. Airway management during anesthesia was performed according to standard clinical practice. No additional intervention was applied for the purpose of the study.

The relationship between preoperative airway assessment findings and actual airway management difficulty was analyzed. The results of this study may help improve preoperative airway evaluation strategies and enhance patient safety in obstetric anesthesia.

详细描述

Difficult airway management is one of the most critical challenges in anesthetic practice and is associated with increased morbidity and mortality. Obstetric patients represent a particularly high-risk population due to pregnancy-related physiological changes such as airway edema, weight gain, reduced functional residual capacity, and increased oxygen consumption. Despite routine use of various preoperative airway assessment tests, their predictive value in obstetric patients remains controversial.

This prospective observational study was conducted to evaluate the reliability of commonly used preoperative airway assessment tests in predicting difficult airway management in patients undergoing cesarean section. The study was performed at Akdeniz University Hospital between August 23, 2023, and August 23, 2024.

Adult obstetric patients scheduled for elective or urgent cesarean section under anesthesia were included. Patients with known airway pathology, prior difficult airway history requiring advanced airway techniques, or incomplete airway assessment data were excluded according to predefined criteria.

Preoperative airway assessment was performed as part of routine anesthetic evaluation and included Mallampati classification, thyromental distance, interincisor distance, neck circumference, and other standard clinical parameters. No additional procedures or interventions were introduced for research purposes. Anesthetic management and airway techniques were determined by the attending anesthesiologist in accordance with institutional standards.

Airway management difficulty was recorded intraoperatively based on predefined clinical criteria, including difficulty with mask ventilation, laryngoscopy, or tracheal intubation. The association between preoperative airway assessment findings and observed airway difficulty was analyzed using appropriate statistical methods. Difficult airway management was defined as the presence of at least one of the following predefined intraoperative criteria:

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
Female
接受健康志愿者

入选标准

  • Adult obstetric patients aged 18 years or older
  • Scheduled for elective or urgent cesarean section
  • Undergoing routine preoperative airway assessment
  • Provided written informed consent

排除标准

  • Known congenital or acquired airway pathology
  • History of difficult airway requiring advanced airway techniques
  • Emergency situations requiring immediate airway management without standard preoperative assessment
  • Incomplete or missing airway assessment data

研究组 & 干预措施

Obstetric Patients Undergoing Cesarean Section

Adult obstetric patients undergoing elective or urgent cesarean section who received standard preoperative airway assessment as part of routine anesthetic care. Airway management was performed according to institutional clinical practice without any study-related intervention.

干预措施: No intervention (observational study) (Other)

结局指标

主要结局

Prediction of Difficult Airway Using Preoperative Airway Assessment Tests

时间窗: During anesthesia induction

The primary outcome is the ability of preoperative airway assessment tests to predict difficult airway management during cesarean delivery. Predictive performance was evaluated using sensitivity, specificity, positive and negative predictive values, and the area under the receiver operating characteristic (ROC) curve (AUC). Difficult airway was defined based on predefined intraoperative criteria such as difficulty in mask ventilation, difficult laryngoscopy, or difficult tracheal intubation as assessed by the attending anesthesiologist.

次要结局

  • Incidence of Difficult Airway in Obstetric Patients(During anesthesia induction)
  • Association Between Individual Airway Assessment Tests and Difficult Airway(During anesthesia induction)

研究者

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

ALİ DEMİRTAŞ

Faculty Member, Department of Anesthesiology and Reanimation

Akdeniz University Hospital

研究点 (1)

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