Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
2019年12月18日 更新者：Ozkan Onal、Selcuk University
Is it Possible That Direct Rigid Laryngoscope-related Ischemia-Reperfusion Injury Occurs in the Tongue During Suspension Laryngoscopy as Detected by Ultrasonography: A Prospective Controlled Study
This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.
研究概览
详细说明
Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes.
In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography.
This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.
研究类型
观察性的
注册 (实际的)
64
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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Selcuklu
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Konya、Selcuklu、火鸡、42100
- Selcuk University
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Konya、Selcuklu、火鸡、42100
- Selcen Celik
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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
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.
描述
Study group
Inclusion Criteria:
- Patients aged 20 years or older
- Patients who undergo suspension laryngoscope procedure
Exclusion Criteria:
- refusal to participate
- age of <20 years
- history of syndromal craniofacial abnormalities
- occurrence of tongue masses
- history of craniofacial surgery
- history of burns, trauma or radiotherapy involving the head and neck region
- neurologic disorders and patients with obstructive sleep apnea syndrome (OSAS)
- active inflammation in the head and neck region
- cervical rigidity limiting neck flexion and head extension
Control group
Inclusion Criteria:
Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck 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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Study
The first group is the study group.
Patients aged 20 years or older and were to undergo suspension laryngoscopy procedure were eligible for inclusion in this group.
Tongue areas were measured twice by submental USG.
The first measurements (TA1) were done immediately after endotracheal intubation before introducing the rigid direct laryngoscope, whereas the second measurements (TA2) were done after the SL procedure and after removing the rigid direct laryngoscope just before extubation.The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.
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This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
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Control
The second group was the control group, which included patients who did not need SL and any head and neck procedures.The tongue areas of these patients were measured twice by submental USG as in the study group.
The TA1 measurements were done immediately after endotracheal intubation, whereas the TA2 measurements were done at the end of the surgical procedure just before extubation.
The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.
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This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
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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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Rate of change in tongue area.
大体时间：2018-2019 (6 months)
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This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.
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2018-2019 (6 months)
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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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Rate of formation in tongue edema.
大体时间：2018 (6 months)
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This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.
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2018 (6 months)
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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。
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)
2018年10月1日
初级完成 (实际的)
2019年4月1日
研究完成 (实际的)
2019年4月1日
研究注册日期
首次提交
2019年12月17日
首先提交符合 QC 标准的
2019年12月18日
首次发布 (实际的)
2019年12月19日
研究记录更新
最后更新发布 (实际的)
2019年12月19日
上次提交的符合 QC 标准的更新
2019年12月18日
最后验证
2019年12月1日
更多信息
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.