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临床试验/NCT04087837
NCT04087837已完成不适用

Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
time taken in tube advancement

研究概览

简要总结

either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

详细描述

In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages. In addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique.

The aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea.

Patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using Magill Forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age:20-65 years
  • •Undergoing oro-maxillofacial surgery
  • •Opening mouth > 3 cm
  • •Denied any systemic disease.
  • •American Society of Anesthesiologists (ASA) class:I-III

排除标准

  • •Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm)
  • •Previous head and neck surgery history
  • •Upper abnormal airway diagnosed
  • •Easily epistaxis
  • •Both sides nasal cavities obstruction

研究组 & 干预措施

bougie group

Experimental

The bougie group: The end of the endotracheal tube was guided to the glottis using the endotracheal tube in the bougie mode under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

干预措施: bougie (Device)

Nasogastric(NG) tube group

Experimental

NG tube group: The end of the endotracheal tube is guided to the glottis by using the endotracheal tube in the nasogastric tube under the direct view of the electronic imaging laryngoscope. The Magill Forceps is used to assist the tip of the endotracheal tube in guiding the glottis.

干预措施: Nasogastric(NG) tube (Device)

control group

No Intervention

Control group: The general anesthesia method of placing the endotracheal tube through the nasal cavity is used to guide the tip of the endotracheal tube to the glottis under the direct view of the electronic imaging laryngoscope.

结局指标

主要结局

time taken in tube advancement

时间窗: 10 minutes

time taken in tube advancement from nostril into trachea in each time interval

success rate of tube advancement and successful first tube attempt

时间窗: 10 minutes

success rate of tube passing through nasal cavity into trachea

次要结局

  • post-intubation induced hoarseness and sore throat(2 days)

研究者

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

Pin-Yang Hu, MD

physician

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (1)

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