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临床试验/NCT03003455
NCT03003455已完成不适用

Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet

University of Iowa2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
257
试验地点
2
主要终点
Nasal trauma

研究概览

简要总结

The purpose of this study is to determine whether nasal intubation over a bougie placed via a nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind nasal endotracheal tube passage.

详细描述

Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic Techniques," CVT) are known to be associated with significant trauma to the patient's nares and the endotracheal tube itself. The investigators propose an alternative technique (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which promises to not only be less traumatic to the patient and the endotracheal tube, but also to take less time to perform and have a higher first-attempt success rate than conventional methods. The investigators propose a randomized prospective interventional study comparing this new technique with conventional technique to see if a significant difference exists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective surgery with an anesthetic plan including asleep nasotracheal intubation

排除标准

  • Patients needing emergent airway protection
  • Patients undergoing emergency surgery
  • Patients whom are known to be pregnant
  • Patients whom are currently anticoagulated (including daily aspirin use)
  • Patients whose anesthetic includes the use of nitrous oxide
  • Patients whom are currently incarcerated
  • Patients 7 years of age or younger
  • Mentally incompetent adults
  • Patients whom refuse involvement in the study

结局指标

主要结局

Nasal trauma

时间窗: 60-90 seconds post-intubation

Bleeding noted on nasopharyngeal exam by surgical resident

次要结局

  • Nasal trauma(5 minutes post-intubation)
  • Time to intubation(Measured immediately post-intubation)
  • First attempt success rate(Measured immediately post-intubation)
  • Need for Magill forceps(Measured Immediately post-intubation)

研究者

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

Abrons, Ron O

Assistant Professor of Anesthesiology

University of Iowa

研究点 (2)

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