TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes
2020年4月26日 更新者:Piotr Palaczyński、Medical University of Silesia
Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes
The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation and the utility of double lumen video endotracheal tubes in patients scheduled for elective thoracic procedures.
研究概览
地位
完全的
详细说明
Most of the thoracic surgery interventions require lung isolation techniques.
Currently the most commonly used lung isolation techniques are double lumen tubes or single lumen tubes with additional use of bronchial blockers.
In both cases fiberoptic bronchoscopy is used for proper placement and maintenance during operation.
Recently double lumen video endotracheal tubes were proposed as a new alternative for lung isolation techniques.
The double lumen video endotracheal tube differs significantly in size and physical characteristics from standard single lumen endotracheal tube and intubation may prove to be challenging even for an experienced practitioner.
Therefore proper prediction of difficult intubation play a crucial role in a clinical setting.
Sensitivity and specificity of existing anthropometric scales and tests used for prediction of difficult intubation seem lacking so new methods such as Thyromental Height Test (TMHT) are being introduced.
It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth.
The main objective of the trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation using double lumen video endotracheal tubes in patients scheduled for elective thoracic surgical procedures.
The secondary aim is to evaluate the utility of double lumen video endotracheal tubes as a novel method of lung separation.
研究类型
观察性的
注册 (实际的)
60
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
-
-
Silesia
-
Zabrze、Silesia、波兰、41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1
-
-
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
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.
描述
Inclusion Criteria:
- patients scheduled for elective thoracic procedures, requiring general anaesthesia and intubation with double lumen endotracheal tubes
- written, informed consent for participation in the trail
- older than 18 years
Exclusion Criteria:
- emergency procedures
- visible anatomic abnormalities
- patients scheduled for awake fibre optic intubation
- lack of consent for participation in the trail
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Double Lumen Endotracheal Tube
Group of patients intubated with Double Lumen Endotracheal Tube.
|
Intubation was performed with Double Lumen Endotracheal Tube.
|
|
Double Lumen Video Endotracheal Tube
Group of patients intubated with Double Lumen Video Endotracheal Tube.
|
Intubation was performed with Double Lumen Video Endotracheal Tube.
|
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 |
|---|---|---|
|
Thyromental height
大体时间:Preoperative (1 day prior to the operation)
|
The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge during routine preoperative anaesthetic visit.
|
Preoperative (1 day prior to the operation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time of Intubation
大体时间:Intraoperatively
|
Time of intubation defined as a time from direct laryngoscopy to proper placement of double lumen endotracheal tube measured with a timer during induction of general anesthesia.
|
Intraoperatively
|
|
Airway trauma
大体时间:Intraoperative
|
During fiberoptic bronchoscopy after the operation airway trauma on the level of bronchus, tracheal bifurcation, trachea and vocal cords were reported, where 0 was defined as no visible trauma, 1 as a redness, 2 as oedema, 3 as hematoma and 4 as active bleeding.
|
Intraoperative
|
|
Usage of fiberoptic bronchoscopy
大体时间:Intraoperatively
|
Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.
|
Intraoperatively
|
|
score in Cormack-Lehane scale
大体时间:Preoperative (1 day prior to the operation)
|
During direct laryngoscopy the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist.
Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.
|
Preoperative (1 day prior to the operation)
|
|
Thyromental distance
大体时间:Preoperative (1 day prior to the operation)
|
The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.
|
Preoperative (1 day prior to the operation)
|
|
Sternomental distance
大体时间:Preoperative (1 day prior to the operation)
|
The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.
|
Preoperative (1 day prior to the operation)
|
|
score in modified Mallampati test
大体时间:Preoperative (1 day prior to the operation)
|
The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.
|
Preoperative (1 day prior to the operation)
|
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
- 研究主任:Hanna Misiołek, MD PhD、Medical University of Silesia
- 学习椅:Szymon Białka, MD、Medical University of Silesia
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 (实际的)
2019年6月1日
初级完成 (实际的)
2019年10月1日
研究完成 (实际的)
2019年10月1日
研究注册日期
首次提交
2019年9月22日
首先提交符合 QC 标准的
2019年9月22日
首次发布 (实际的)
2019年9月24日
研究记录更新
最后更新发布 (实际的)
2020年4月28日
上次提交的符合 QC 标准的更新
2020年4月26日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
其他研究编号
- TMHT-04
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不
研究美国 FDA 监管的设备产品
不
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