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临床试验/NCT00272194
NCT00272194已完成4 期

The Ambu® Laryngeal Mask as an Intubation Conduit For Patients Undergoing Routine General Anesthesia

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2005年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
160
试验地点
2
主要终点
Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids

研究概览

简要总结

The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.

详细描述

The laryngeal mask airway (LMA) is an established supra-glottic device that provides better ventilation than traditional mask ventilation and is less invasive than endotracheal intubation. Being less invasive, it is commonly used for short elective surgical procedures. Its ability to be both easily and rapidly inserted also makes it useful as a rescue device in difficult and failed intubations. Being a supra-glottic device, the LMA does not protect patients from regurgitation and aspiration. Additionally, patients requiring alternative positions, such as prone or lateral, or those having surgery in the neck/head area are contra-indicated for LMA use due to risk of possible movement of the LMA, and therefore possible loss of airway patency. Thus, the LMA can be utilized as an intermediary method of airway management to endotracheal intubation.

The manufacturer of the reusable LMA-ClassicTM states that "the success rate of intubation through the standard LMA-ClassicTM is highly variable (30-93%)," whereas the success rate of the disposable version, LMA-UniqueTM, has been found to be only 21%1. An LMA specifically designed for intubation now exists and improves the success rate of intubation. The reusable LMA-FastrachTM or Intubating-LMATM (ILMA) is a rigid and anatomically curved airway tube. It is wide enough to accommodate 8.0 mm cuffed endotracheal tubes. Attached to the ILMA is a rigid handle to aid in one-handed insertion, removal, and adjustment. Success rates for intubating through the ILMA are 96.5% when inserted blindly and 100% with fiberoptic guidance2. No disposable version of the ILMA presently exists.

The Ambu® Laryngeal Mask (ALMA) is a new disposable laryngeal mask with an anatomical curve similar to the ILMA. The reasons for the use of disposable products can be many and varied. The residual risk of the transmission of germs and protein particles represents one indication. If supra-glottic airway devices are used electively or in emergencies, e.g. for HIV-positive patients or those infected with Creutzfeldt-Jacob disease, reuse of the products is not desirable. Disposable products, on the other hand, offer the benefit that the transmission of germs is avoided, and at the same time offer considerable economic advantages due to the much lower price of the product. The disposable ALMA has been proven as an effective and safe supra-glottic airway device3. Upon fiberoptic visualization through its shaft, the glottis was visualized 91.5% of the time, indicating that this device may be used as an intubation conduit. The purpose of this study is to determine if the ALMA is also safe and effective as an intubating conduit. The hypothesis is that the ALMA will perform as well as, if not better than the LMA-UniqueTM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single

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

  • The patient is ASA 1-3 presenting for an elective surgical procedure
  • The patient is 18-65 years of age
  • The patient weighs > 50 kg with a BMI < 30 kg/m2
  • The patient has a Mallampati grade I -III airway
  • The patient is undergoing general anesthesia with controlled ventilation for minor routine surgical procedures
  • The period of anesthesia time is >30 minutes

排除标准

  • The patient is an ASA classification 4
  • The patient is < 18 or >65 years of age
  • The patient weighs < 50 kg or has a BMI > 30 kg/m2
  • The patient has a history of inadequate cervical mobility
  • The patient has a history or signs of difficult airway management
  • The patient has a Mallampati grade IV Class airway
  • The patient has a mouth opening < 2.5 cm
  • The patient has an oral cavity disease
  • The patient has a cervical malformation
  • The patient had upper respiratory tract symptoms in the previous 10 days
  • The patient is to have surgery performed to the head/neck or thoracoabdominal cavities needing to be paralyzed, or in the lateral/prone position
  • The patient is considered at risk of aspiration (non-fasted, gastroesophageal reflux/disease)

结局指标

主要结局

Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids

次要结局

  • vital signs, oxygen saturation, end-tidal carbon dioxide

研究者

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

Carin A. Hagberg

Professor and Chairman, Joseph C. Gable, M.D., Endowed Chair

The University of Texas Health Science Center, Houston

研究点 (2)

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