跳至主要内容
临床试验/NCT01749033
NCT01749033已完成不适用

A New Insertion Technique for Laryngeal Mask Airway

Northwestern University2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
2
主要终点
Number of Subjects Who Present With Postoperative Sore Throat

研究概览

简要总结

A laryngeal mask airway ("LMA") is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an "endotracheal tube" (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the "working" end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the "ELLIA" method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.

详细描述

The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • ASA (American Society of Anesthesiologists patient fitness category) I, II, III
  • Age 18-90
  • General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included

排除标准

  • Small mouth opening
  • Preoperative sore throat/dysphagia/dysphonia
  • Patients at increased risk for aspiration
  • Morbid obesity BMI > 40
  • Untreated chronic GERD
  • Pregnancy
  • Suspected supraglottic abnormalities
  • Need for oral-pharyngeal suctioning
  • Undergoing oral and nasal surgery
  • Intubation or any oral instrumental manipulations other than
  • LMA placements intraoperatively or postoperatively

结局指标

主要结局

Number of Subjects Who Present With Postoperative Sore Throat

时间窗: 24 hours

The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.

The Primary Outcomes for This Study Will be Postoperative Dysphagia.

时间窗: 24 hours

The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.

The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia

时间窗: 24 hours

The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.

The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.

时间窗: 24 hours

The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.

次要结局

  • Blood on LMA After Removal(Immediately after LMA removal)
  • Severity of Sore Throat(24 hours)

研究者

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

David Walega

Principal Investigator

Northwestern University

研究点 (2)

Loading locations...

相似试验