Comparison of Double Lumen Tube Placement Techniques
2018年6月20日 更新者：Igor Zhukov、Emory University
Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
研究概览
地位
终止
详细说明
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope.
A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure.
The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.
研究类型
介入性
注册 (实际的)
19
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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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Hospital
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Atlanta、Georgia、美国、30308
- Emory University Hospital Midtown
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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:
- Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
- Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
- Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR >1
- Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
- Patients who require a rapid-sequence intubation
- Patients undergoing emergency procedures
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：卫生服务研究
- 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 |
|---|---|
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实验性的：ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet.
The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature.
Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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有源比较器：GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet.
The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube.
GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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有源比较器：Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
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Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet.
The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement.
After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.
其他名称：
Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade.
The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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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 |
|---|---|---|
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Mean Time to Place the Double-lumen Endobronchial Tube
大体时间：during laryngoscope placement, up to 120 seconds
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The time taken for successful intubation will be recorded by the anesthetist.
The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds.
A higher duration noted is indicative of a longer time taken for successful intubation.
0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)
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during laryngoscope placement, up to 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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Success Rate of First Endobronchial Intubation Attempt
大体时间：during laryngoscope placement, up to 120 seconds
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The rate of first intubation attempt success will be recorded by the anesthetist.
A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .
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during laryngoscope placement, up to 120 seconds
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Assessment of Difficulty of Intubation
大体时间：during laryngoscope placement, up to 120 seconds
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The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement.
The subjective scores range from 0-10; where 0=worst, 10=best.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases With Complications
大体时间：during laryngoscope placement, up to 120 seconds
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Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture.
The responses are recorded as Yes or No for each item.
A 'yes' response indicates a complication.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases of Voice Change
大体时间：Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No).
The subjective answer given by the patient will be recorded.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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Throat Pain
大体时间：Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced.
An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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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：Igor Zhukov, MD、Emory University
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
2015年7月1日
初级完成 (实际的)
2017年7月27日
研究完成 (实际的)
2017年7月27日
研究注册日期
首次提交
2015年7月9日
首先提交符合 QC 标准的
2015年7月10日
首次发布 (估计)
2015年7月13日
研究记录更新
最后更新发布 (实际的)
2018年7月27日
上次提交的符合 QC 标准的更新
2018年6月20日
最后验证
2018年6月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB00081067
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.