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Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients

2013年3月15日 更新者：John Laffey

The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.

The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.

The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.

The Baska mask is a new supraglottic airway device. It's features include:

  1. Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
  2. Improved cuff seal during the inspiratory phase of positive pressure ventilation
  3. An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
  4. Integrated bite-block to reduce the risk of patients biting and blocking the airway.

This study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.

Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.

Standard anesthetic preassesment and anesthesia will be provided.

Consenting patients will be randomly allocated to either of the 2 study groups.

Protocol for airway size selection and attempts at placement will be followed.

The investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications related to device use and other.

Follow up will be performed.

The investigators have two primary hypotheses:

  1. That the Baska mask is non-inferior to LMA in respect if first placement attempt success rate. A greater than 15% difference in success rate will be considered a clinically important difference and will disprove this hypothesis.
  2. The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with Baska as compared to the LMA device seal pressure will be considered a clinically important difference.

Interim analysis will be performed once 75 patients are recruited per group. This is reasonable as this figure exceeds that required to prove or disprove the primary hypothesis regarding the seal pressure. The study will only be stopped at this stage if the non-inferiority hypothesis is disproven with P value < 0.01

In addition to the above the investigators will evaluate a number of secondary outcomes.

研究类型

介入性

注册 (实际的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 爱尔兰
      • Galway、爱尔兰
        • Galway University Hospitals

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 85年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female
  • Written informed consent
  • ASA 1-3
  • No relevant allergies
  • Body-mass index (BMI) 35 or less
  • Age 16-85
  • Non-urgent surgery of planned duration under 4 hours

Exclusion Criteria:

  • Inability of patient/parent to understand or consent for the trial
  • Neck pathology
  • Previous or anticipated problems with the upper airway or upper GI tract
  • BMI >35
  • Predicted or previously documented difficult airway
  • Live Pregnancy
  • Increased risk for Gastric Aspiration

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Baska mask
In this arm the Baska mask will be used as the airway management device
设备：supraglottic airway placement and use
有源比较器：single use laryngeal mask airway device (LMA)
in this arm a single use LMA device will be used for airway management.
设备：supraglottic airway placement and use

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of successful placement of the supraglottic device on first attempt
大体时间：within 30 minutes of commencement of general anesthesia
The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.
within 30 minutes of commencement of general anesthesia
Seal pressure of the supraglottic device
大体时间：Within 30 minutes of commencement of general anesthesia
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.
Within 30 minutes of commencement of general anesthesia

次要结果测量

结果测量
措施说明
大体时间
Overall rate of successful placement of the supraglottic device
大体时间：Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts
大体时间：Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement
大体时间：Within 30 minutes of commencement of general anesthesia
Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score
大体时间：within 30 minutes of commencement of general anesthesia
the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.
within 30 minutes of commencement of general anesthesia
vitals parameter stability
大体时间：in the period immediately before and within the first 35 minutes of general anesthesia
The investigators will record non-invasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after induction of general anesthesia and after placement of the airway device.
in the period immediately before and within the first 35 minutes of general anesthesia
Laryngeal view obtained on fiberoptic assessment
大体时间：within 2 hours of commencement of general anesthesia
The investigators will perform this when feasible.
within 2 hours of commencement of general anesthesia
Complication rates
大体时间：from the moment general anesthesia commenced up to 3 days postoperatively

Complications specifically monitored will be: blood staining, laryngospasm, lip damage, throat pain, dysphagia, dysphonia, heartburn, nausea and vomiting.

The investigators will record other complications related to the use of the device, including but not limited to: desaturation, need to reposition device or switch to alternative device, teeth damage, regurgitation, aspiration
from the moment general anesthesia commenced up to 3 days postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

John Laffey

调查人员

  • 首席研究员：Patrick Neligan, FFARCSI、Galway University Hospitals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年11月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2012年12月17日

首先提交符合 QC 标准的

2012年12月17日

首次发布 (估计)

2012年12月20日

研究记录更新

最后更新发布 (估计)

2013年3月19日

上次提交的符合 QC 标准的更新

2013年3月15日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • C.A.724

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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