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临床试验/NCT05832554
NCT05832554已完成不适用

Comparison of the Effects of Nasopharyngeal and Oropharyngeal Airway Use on Gastric Insufflation in Patients Who Are Expected to Have Difficult Mask Ventilation

Diskapi Teaching and Research Hospital2 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Difference in antral area sizes

研究概览

简要总结

The goal of this clinical trial is to compare the effects of nasopharyngeal and oropharyngeal airway on gastric insufflation in patients undergoing general anesthesia and expected difficult mask ventilation. The main questions it aims to answer are:

  • Is there a difference between the presence of gastric insufflation in the use of nasopharyngeal and oropharyngeal airways?
  • Is there a difference between the antral area sizes measured before and after ventilation After general anesthesia induction, nasopharyngeal or oropharyngeal airway will be placed in participants and real-time ultrasonographic gastric antral area imaging will be performed during mask ventilation. Researchers will compare the effects of nasopharyngeal and oropharyngeal airway use on gastric insufflation.

详细描述

Patients who are expected to have difficult mask ventilation and receive general anesthesia will be included in the study. After preoperative gastric antral area measurements of the patients by ultrasonography, preoxygenation will be applied and anesthesia induction will be performed. Real-time gastric ultrasonography will be performed during pressure-controlled mask ventilation for 2 minutes after nasopharyngeal or oropharyngeal airway insertion, and then antral area measurement will be repeated. After the trachea was intubated, the antral area measurement was once again performed. At the 30th, 60th, 90th and 120th seconds of ventilation, patients' SpO2, EtO2, EtCO2, peak airway pressure, tidal volume, leak volumes and hemodynamic changes will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving general anesthesia
  • ASA score I-II-III
  • At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al.

排除标准

  • Patients who did not give informed consent
  • Risk of aspiration
  • Respiratory disease
  • Facial, oropharyngeal or nasopharyngeal pathology
  • Pregnancy

结局指标

主要结局

Difference in antral area sizes

时间窗: During 2 minutes mask ventilation

Difference in antral area sizes measured by ultrasound imaging before and after ventilation

Presence of gastric insufflation

时间窗: During 2 minutes mask ventilation

Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use

次要结局

  • Leakage volume(During 2 minutes mask ventilation)

研究者

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

derya özkan

Professor MD

Diskapi Teaching and Research Hospital

研究点 (2)

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