First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance
2026年7月9日 更新者：Shin Kyung Won, MD、Seoul National University Hospital
First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance: Conventional vs. Video-assisted Supraglottic Airway Devices, a Randomized Controlled Trial
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia.
A total of 204 participants will be randomly assigned to one of the two groups.
The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device.
Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events.
The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
204
阶段
- 不适用
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 19 years or older.
- Scheduled to undergo elective surgery under general anesthesia requiring tracheal intubation.
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- Emergency surgery.
- History of gastroesophageal reflux disease.
- Previous surgery or radiotherapy involving the upper airway.
- Severely loose teeth.
- Any condition considered by the investigator to make study participation inappropriate.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Video-assisted Supraglottic Airway Device
Participants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia.
|
A video-assisted supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
其他名称：
|
|
有源比较器：Conventional Supraglottic Airway Device
Participants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia.
|
A conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
其他名称：
|
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 |
|---|---|---|
|
First-attempt success rate of tracheal intubation through the supraglottic airway device
大体时间：At the time of tracheal intubation during induction of general anesthesia
|
The proportion of participants in whom tracheal intubation through the assigned supraglottic airway device is successfully achieved on the first attempt without fiberoptic guidance.
|
At the time of tracheal intubation during induction of general anesthesia
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intubation time
大体时间：During induction of general anesthesia
|
Time required for tracheal intubation through the assigned supraglottic airway device.
|
During induction of general anesthesia
|
|
Number of intubation attempts
大体时间：During induction of general anesthesia
|
Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device.
|
During induction of general anesthesia
|
|
Overall intubation success rate
大体时间：During induction of general anesthesia
|
Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts.
|
During induction of general anesthesia
|
|
Postoperative sore throat
大体时间：1 hour and 24 hours after surgery
|
Incidence and severity of postoperative sore throat.
|
1 hour and 24 hours after surgery
|
|
Postoperative hoarseness
大体时间：1 hour and 24 hours after surgery
|
Incidence of postoperative hoarseness.
|
1 hour and 24 hours after surgery
|
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。
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 (估计的)
2026年8月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2029年8月1日
研究注册日期
首次提交
2026年7月9日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月15日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 2605-119-1747
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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