Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use (MEASURE-ILD)
Development of an Intelligent Video Laryngoscope and Preliminary Verification for Emergency Application
The investigators are developing a video laryngoscope equipped with artificial intelligence technology to enable automatic identification of key airway anatomical structures and real-time guidance during intubation, with the aim of improving the success rate and efficiency of endotracheal intubation in emergency settings.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jintao Wei wei
- 电话号码：19560480512
- 邮箱：weijintao@zju.edu.cn
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国
- 招聘中
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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接触：
- Jintao Wei
- 电话号码：+86 19560480512
- 邮箱：weijintao@zju.edu.cn
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Shaoxing、Zhejiang、中国、312000
- 招聘中
- Shaoxing Central Hospital
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接触：
- dongzhi liu
- 邮箱：weijintao@zju.edu.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient inclusion criteria: Adult patients in critical condition requiring endotracheal intubation via laryngoscopy (age ≥ 18 years).
Exclusion Criteria:
- pregnant women, prisoners, recent history of airway surgery, oral or pharyngeal malformations, inability to perform randomization due to the need for emergency endotracheal intubation, or when the investigator deemed it necessary or contraindicated to use AIVL, VL, or DL during the first intubation attempt.
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Video Laryngoscope(VL)
Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using a conventional video laryngoscope (VL), without AI-assisted anatomical identification or intubation guidance. |
A conventional video laryngoscope will be used for the first endotracheal intubation attempt. The device displays the airway image without AI-assisted identification of anatomical structures or real-time AI intubation guidance. |
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实验性的：AI-assisted Video Laryngoscope (AIVL)
Participants randomized to this arm (n=60) will undergo the first endotracheal intubation attempt using an AI-assisted video laryngoscope (AIVL), which provides real-time identification of airway anatomical structures and intubation guidance. Operators will receive standardized training on the device controls, guidance interface, and image display before use. Operators may decide whether to follow the AI guidance. |
When using the AIVL for the first attempt at laryngoscopy intubation, the operator shall receive pre-procedural training, which primarily covers the functional buttons, the prompt interface, and image display. |
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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First-pass intubation success rate
大体时间：The time from enrollment to completion of intubation (usually within 10 minutes).
|
Proportion of participants with successful endotracheal tube placement on the first laryngoscopic attempt, confirmed by end-tidal carbon dioxide monitoring. |
The time from enrollment to completion of intubation (usually within 10 minutes).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intubation time
大体时间：The time from enrollment to completion of intubation (usually within 10 minutes).
|
Time in seconds from insertion of the laryngoscope into the oral cavity until the endotracheal tube passes through the glottis. |
The time from enrollment to completion of intubation (usually within 10 minutes).
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Severe complications occurring within 2 minutes after intubation were defined as severe hypoxemia (peripheral SpO₂ <80%), severe hypotension (systolic blood pressure <65 mmHg), initiation of vasoactive agents, cardiac arrest, or death.
大体时间：From enrollment to the 2 minutes after intubation
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From enrollment to the 2 minutes after intubation
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AI recall
大体时间：The time from enrollment to completion of intubation (usually within 10 minutes).
|
True-positive anatomical detections divided by true-positive plus false-negative detections, assessed against reference annotations. |
The time from enrollment to completion of intubation (usually within 10 minutes).
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Duration of mechanical ventilation
大体时间：From enrollment to the end of treatment at 8 weeks
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Duration of mechanical ventilation, measured in days. |
From enrollment to the end of treatment at 8 weeks
|
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28-day all-cause mortality
大体时间：From enrollment through day 28.
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Proportion of participants who die from any cause within 28 days after enrollment. |
From enrollment through day 28.
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ICU length of stay
大体时间：From enrollment through the end of treatment, up to 8 weeks.
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Duration of intensive care unit stay, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
|
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Total hospital length of stay
大体时间：From enrollment through the end of treatment, up to 8 weeks.
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Total duration of hospitalization, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
|
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AI precision
大体时间：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
True-positive anatomical detections divided by true-positive plus false-positive detections, assessed against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
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AI specificity
大体时间：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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True-negative assessments divided by true-negative plus false-positive assessments, assessed against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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AI F1 score
大体时间：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
Harmonic mean of precision and recall: 2 x precision x recall / (precision + recall). |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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Mean average precision (mAP)
大体时间：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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Mean of average precision across the evaluated anatomical classes against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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