跳至主要内容
临床试验/CTRI/2019/12/022214
CTRI/2019/12/022214尚未招募不适用

Comparison of preoperative ultrasonographic technique, preoperative MRI/CT scan imaging and digital examination technique for nostril selection prior to nasotracheal intubation: A randomised controlled trial

Dr Shagun Bhatia Shah1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Ease of introduction of nasotracheal tube into the selected nostril

研究概览

简要总结

This study is a prospective, interventional, four-arm, single centric randomised controlled study comparing the ease of intubation between four techniques of determining nasal patency in 120 patients undergoing head and neck oncosurgery requiring nasal intubation. The patients shall be randomly allocated into one of the four groups (Group D: Digital group; Group I: Imaging group; Group S: Sonography group and Group F: Fiberoptic bronchoscopy group).  The primary outcome measures would be ease of nasotracheal tube insertion through the selected nostril into the oral cavity. The secondary outcome measures pertaining to the nasotracheal tube would be the number of attempts at intubation, use of a smaller sized endotracheal tube and complications like bleeding/ tissue trauma and endotracheal tube cuff rupture noted immediately after nasotracheal intubation. Another secondary outcome measure would be the ease of nasogastric tube insertion.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Weight 40-80kg Patients scheduled to undergo nasotracheal intubation for head and neck oncosurgery.

排除标准

  • Patient refusal Pre-existing coagulopathy.

结局指标

主要结局

Ease of introduction of nasotracheal tube into the selected nostril

时间窗: At the time of nasotracheal intubation

次要结局

  • Number of intubation attempts(At the time of nasotracheal intubation)
  • Bleeding and trauma(At the time of nasotracheal intubation)
  • Use of smaller sized nasotracheal tube(At the time of nasotracheal intubation)
  • Endotracheal tube cuff rupture(Immediately after nasotracheal tube insertion on cuff inflation)
  • Ease of nasogastric tube insertion(At the time of nasogastric tube insertion (1 min after nasotracheal tube insertion))

研究者

发起方
Dr Shagun Bhatia Shah
申办方类型
Other [Principal Investigator]

研究点 (1)

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