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临床试验/NCT02033564
NCT02033564已完成不适用

Does the Incidence of Sore Throat Increase With the Use of a Traditional Intubation Blade or the Glidescope

Jason Ngo, B.S.2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
2
主要终点
Sore Throat

研究概览

简要总结

The purpose in this study is to determine whether there is a difference in the incidence of postoperative sore throat when using the GlideScope™ versus a traditional intubation blade involving patients that are not anticipated to have a difficult airway.

详细描述

The goal of this study is to determine whether the use of the GlideScope™ video laryngoscope during intubation leads to a greater or lesser incidence of sore throat when compared to traditional laryngoscope blades used for intubation, such as the Macintosh or Miller blade. During postoperative checks by a board certified anesthesiologist at the Albany Medical Center (AMC) Hospital, it was noticed that patients who reported sore throat often required intubation with the GlideScope™. Standard of care at the AMC Hospital dictates that the Glidescope is used as a "rescue" device for failed direct laryngoscopy on a difficult airway; if traditional direct laryngoscopy with a Macintosh or Miller blade cannot provide adequate laryngeal views, progression to a different airway device such as the Glidescope or fiberoptic scope is indicated. The initial attempt with direct laryngoscopy on a difficult airway often requires utilization of McGill forceps, which increases the chance of upper airway injury prior to the rescue attempt with the GlideScope. Consequently, it is difficult to determine whether patients' reports of post-operative sore throat are caused by the irritation inflicted by the multiple laryngoscopic attempts required in patients where the Glidescope was needed as a rescue method, or whether it is due to the actual utilization of the Glidescope itself.

Previous studies have shown that the use of a GlideScope™ decreases the likelihood of upper airway injury by decreasing the lower mean force applied during laryngoscopy when compared to a Macintosh laryngoscope; however, this study was done using manikins and it is not known whether this result can be translated to a patient oriented outcome. Another study compared the GlideScope™ to direct laryngoscopy for nasotracheal intubation. Their results suggested that the incidence of postoperative moderate or severe sore throat was significantly reduced with use of the GlideScope™ videolaryngoscope. However, other studies have shown increased incidence of postoperative sore throat with Glidescope usage when compared to other videolaryngoscopes and conventional Macintosh laryngoscope as a primary laryngoscopy method. In light of these studies, none have attempted a direct comparison of a Glidescope with conventional Macintosh/Miller laryngoscope blades with incidence of sore throat as a primary outcome of interest.

The purpose in this study is to determine whether there is a difference in the incidence of postoperative sore throat when using the GlideScope™ versus a traditional intubation blade involving patients that are not anticipated to have a difficult airway. Exclusion of patients with difficult airways allows us to perform direct comparisons with the Glidescope and conventional direct laryngoscopy without compromising standard of care or increasing patient risk, which will be determined by the use of standard of care preoperative exams.

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 (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, aged 18 - 80 years old.
  • Able to provide written informed consent and to comply with all study procedures
  • Scheduled for elective inpatient or outpatient surgery requiring general anesthesia and orotracheal intubation.

排除标准

  • Known difficult airway based on prior medical history
  • American Society of Anesthesiologists physical status score > IV
  • Presence of abnormal cervical spine movement (normal > 90°)
  • Airway Mallampati score ≥ III
  • Thyromental distance ≥ 6
  • Upper lip bite test ≥ 3
  • Degree of retrognathia
  • Previous medical history indicating patient has a known difficult airway
  • Judgment that patient will require intubation post-operatively
  • Are emergency surgery cases
  • Are Ear-Nose-Throat (ENT) or neck surgery cases
  • Have a planned post-operative ICU stay
  • Inadequate Nil Per Os (NPO) status prior to surgical case
  • Prisoner status

结局指标

主要结局

Sore Throat

时间窗: Within 24 hours post-operatively

Based on subjective yes/no reply by patient

次要结局

未报告次要终点

研究者

发起方
Jason Ngo, B.S.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jason Ngo, B.S.

Medical Student

Albany Medical College

研究点 (2)

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