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临床试验/NCT03210922
NCT03210922已完成不适用

Effect of Semirigid Cervical Collar During Nasotracheal Intubation by Glidescope in the Elective Cervical Spinal Surgical Patients: a Study of Clinical Predictors and Outcomes

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2017年7月13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
181
试验地点
2
主要终点
Nasointubation Time

研究概览

简要总结

Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes

详细描述

Clinically used cervical orthoses can effectively limit cervical spine motion in all direction and provide protection. Among them, the restriction by Miami semirigid collar was superior, with the least tissue-interface pressure of neck. It is one of the most used semirigid collars for patients' protection in the operating theatre. However, the presence of the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/ or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy and requires less technical skill than fiberoptic tracheal intubation. The investigation was to assess the effect of cervical collar on nasotracheal intubation and potential hazard factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled for elective cervical spinal surgery.

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 (Outcomes Assessor)

盲法说明

The anesthetic induction and nasotracheal induction are performed by one anesthesiologist. Another anesthesiology calculated the intubation time according to the video recording.

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective cervical spine surgery
  • scheduled for nasotracheal intubation
  • not requiring orthosis for prophylactic protection

排除标准

  • Risk of pulmonary aspiration of gastric contents
  • Pathology of the nasal cavity
  • Abnormal coagulation function
  • Extensive and severe cord compression
  • Refused to sign informed consent.

研究组 & 干预措施

Non-collar group

No Intervention

Standard of anesthetic care and nasointubation with patient not wearing the Miami cervical collar.

Collar group

Experimental

Standard of anesthetic care and nasointubation with patient wearing the Miami cervical collar.

干预措施: Miami cervical collar (Device)

结局指标

主要结局

Nasointubation Time

时间窗: Intraoperative

intubation time assisted by Glidescope

次要结局

  • subjective scoring of ease of intubation(Intraoperative)
  • magill forceps for nasointubation(Intraoperative)

研究者

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

vghtpe user

Principal Investigator, Associate Professor

Taipei Veterans General Hospital, Taiwan

研究点 (2)

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