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临床试验/NCT03240042
NCT03240042已完成不适用

Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2017年10月17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
118
试验地点
2
主要终点
cuff pressure

研究概览

简要总结

When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasotracheal and orotracheal intubation.

详细描述

When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. The most important structure is the recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The pressure created by the retractor may be related to postoperative dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or orotracheal tube can both be applied to general anesthesia for the anterior cervical spine surgery. The option depends on the surgeons' preference. Though both approaches end at the trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth angle, on the opposite side of surgical approach. The investigators hypothetize this difference in location results in different degree of deviation and increase of cuff pressure. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasoendotracheal and oroendotracheal intubation.

Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure from this tube may be relatively evenly distributed, and the pressure on the surrounding tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint) and post-ACSS dysphonia (secondary endpoint).

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 20-80 Scheduled cervical spine surgery, anterior approach

排除标准

  • Severe spinal stenosis and requiring fiberoptic intubation
  • Unstable spine and require orthosis
  • Hisotory of difficult intubation
  • History of cervical spine or neck surgery
  • Coagulopathy
  • Nasal pathology
  • Lack of informed consent
  • History of previous cervical spine or neck surgery
  • Anterior cervical spine surgeries after trauma, tumour resection, or spinal infection
  • Preoperative dysphonia or dysphagia, regardless of the aetiology

研究组 & 干预措施

Nasoendo group

Experimental

Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.

干预措施: nasotracheal intubation (Procedure)

Oroendo group

Other

Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.

干预措施: orotracheal intubation (Procedure)

结局指标

主要结局

cuff pressure

时间窗: from time of randomization until postoperative 30 days

cuff pressure of endotracheal tube

次要结局

  • dysphonia(from time of randomization until postoperative 30 days)
  • sore throat(from time of randomization until postoperative 30 days)
  • dysphagia(rom time of randomization until postoperative 30 days)

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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