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临床试验/NCT00706823
NCT00706823已完成不适用

A Randomized Clinical Comparison of the Intersurgical I-gel and the Laryngeal Mask Airway Unique in Non-Obese Adult Patients During General Surgery

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Time Required for Intubation

研究概览

简要总结

The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.

详细描述

During the past decade, several pharyngeal airways have been introduced for airway management, such as the Laryngeal Mask Airway (LMA), the Cobra perilaryngeal airway, the Esophageal Tracheal Combitube (ETC), the EasyTube, the Laryngeal Tube6, and the Streamlined Liner of the Pharyngeal Airway (SLIPA). These airway devices have become very popular because of their ability to maintain an airway without perturbing the trachea and can be used in patients without muscle relaxation who are only lightly anesthetized.

The LMA Classic (cLMA) generally provides an adequate airway, but certain problems remain:

  1. In 8-33% of LMA placements, more than one attempt is required.
  2. It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients).
  3. The device does not protect the airway from aspiration of gastric contents.
  4. It does not provide an airtight seal around the larynx (the usual pressures causing leakage of gas being 15-20 cm H20). Consequently, the device may function poorly during positive-pressure ventilation.
  5. The esophagus is included within the rim of the LMA in 10-15% of patients, directly exposing the esophagus to positive airway pressures. This often results in insufflation of the stomach and postoperative discomfort.

The LMA Unique (uLMA) is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.

The i-gel (Intersurgical Ltd., Wokingham, England) is a cuffless, single-use supraglottic airway device designed to provide a more effective seal than the uLMA, thus eliminating problems 3-5 described above with the addition of a gastric drain. Made of a gel-like thermoplastic elastomer, the i-gel has an anatomically-designed mask that allows quick, easy insertion and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff. In a preliminary study, the peak airway pressures were found to be above 30 cm H2O with a sustained leak pressure of 24 cm H2O versus an average of 18-21 cm H2O seen with the cLMA. According to the 100 patient trial, the i-gel is easier to insert, it has better sealing properties and there is no cuffed inflates.

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

  • The subjects will be adult surgical candidates aged 18-80, ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
  • Both male and female patients will be included.

排除标准

  • Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
  • obesity, (BMI > 35 kg/m2)
  • history of gastric regurgitation, heart burn, ileus or "full stomach"
  • history of low pulmonary compliance or high pulmonary resistance
  • known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
  • pharyngeal pathology
  • upper airway obstruction due to laryngeal pathology

结局指标

主要结局

Time Required for Intubation

时间窗: duration of intubation

The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).

Leak Pressure

时间窗: duration of intubation

After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.

次要结局

  • Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization(after intubation)
  • Number of Attempts(Before intubation)
  • Level of Difficulty for Intubation(duration of intubation)
  • Number of Participants With Oropharyngeal Discomfort(post operative, immediately and 24 hrs after intubation)

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, MD Endowed Chair

The University of Texas Health Science Center, Houston

研究点 (2)

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