Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
2017年8月8日 更新者：Rainer Lenhardt、University of Louisville
Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation.
Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria).
All patients will be intubated with a GVL.
Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
140
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
-
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville Hospital
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-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- BMI > 35
- Thyromental distance < 6 cm
- Sterno-mental distance < 12 cm
- Mallampati grade 3 and 4
- Interincisor distance < 38 mm
- Status of dentition: presence of buckteeth
- Neck movement < 35°
- Neck circumference >43 cm at the level of the thyroid cartilage
- Patients with immobilized cervical spine (C-collar in place).
- History of difficult laryngoscopy or intubation
Exclusion Criteria:
- Full stomach
- Hiatal hernia
- Severe GERD (Gastroesophageal reflux disease)
- Tumors of the upper airway
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：支持治疗
- 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 |
|---|---|
|
有源比较器：Control
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
|
pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
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实验性的：Intervention
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
|
The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
其他名称：
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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 |
|---|---|---|
|
Intubation Time
大体时间：120 seconds
|
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above).
Interim bag and mask time, if needed, will not be included in the intubation time.
More than 5 attempts or 120 s are regarded as failure of intubation.
If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
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120 seconds
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Number of Intubation Attempts
大体时间：30 minutes
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counted as each approach of the ETT to the glottic entrance.
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30 minutes
|
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Neck Movement
大体时间：30 minutes
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One observer will video-record the entire intubation procedure.
At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation.
Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement.
Results are reported as total with mild, moderate, or severe neck movement.
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30 minutes
|
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Laryngeal View Grade of 1 or 2
大体时间：30 minutes
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The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
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30 minutes
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Ease of Intubation
大体时间：2-4 hours after intubation
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After completion of the procedure the intubator will be asked to score the ease of intubation.
To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
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2-4 hours after intubation
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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。
调查人员
- 首席研究员：Rainer Lenhardt, MD、University of Louisville
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2010年8月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2010年7月22日
首先提交符合 QC 标准的
2010年10月5日
首次发布 (估计)
2010年10月6日
研究记录更新
最后更新发布 (实际的)
2017年9月8日
上次提交的符合 QC 标准的更新
2017年8月8日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- UofL IRB #10.0300
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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