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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jintao Wei wei
- 電話番号：19560480512
- メール：weijintao@zju.edu.cn
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 募集
- Second Affiliated Hospital, Zhejiang University, School of Medicine
-
コンタクト：
- Jintao Wei
- 電話番号：+86 19560480512
- メール：weijintao@zju.edu.cn
-
Shaoxing、Zhejiang、中国、312000
- 募集
- Shaoxing Central Hospital
-
コンタクト：
- dongzhi liu
- メール：weijintao@zju.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First-pass intubation success rate
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intubation time
時間枠：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).
|
|
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.
時間枠：From enrollment to the 2 minutes after intubation
|
From enrollment to the 2 minutes after intubation
|
|
|
AI recall
時間枠：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).
|
|
Duration of mechanical ventilation
時間枠：From enrollment to the end of treatment at 8 weeks
|
Duration of mechanical ventilation, measured in days. |
From enrollment to the end of treatment at 8 weeks
|
|
28-day all-cause mortality
時間枠：From enrollment through day 28.
|
Proportion of participants who die from any cause within 28 days after enrollment. |
From enrollment through day 28.
|
|
ICU length of stay
時間枠：From enrollment through the end of treatment, up to 8 weeks.
|
Duration of intensive care unit stay, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
|
|
Total hospital length of stay
時間枠：From enrollment through the end of treatment, up to 8 weeks.
|
Total duration of hospitalization, measured in days. |
From enrollment through the end of treatment, up to 8 weeks.
|
|
AI precision
時間枠：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.
|
|
AI specificity
時間枠：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
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.
|
|
AI F1 score
時間枠：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.
|
|
Mean average precision (mAP)
時間枠：Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
Mean of average precision across the evaluated anatomical classes against reference annotations. |
Video acquired from enrollment to completion of intubation, usually within 10 minutes.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。