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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jintao Wei wei
- Numéro de téléphone: 19560480512
- E-mail: weijintao@zju.edu.cn
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine
- Recrutement
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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Contact:
- Jintao Wei
- Numéro de téléphone: +86 19560480512
- E-mail: weijintao@zju.edu.cn
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Shaoxing, Zhejiang, Chine, 312000
- Recrutement
- Shaoxing Central Hospital
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Contact:
- dongzhi liu
- E-mail: weijintao@zju.edu.cn
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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First-pass intubation success rate
Délai: The time from enrollment to completion of intubation (usually within 10 minutes).
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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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intubation time
Délai: 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.
Délai: 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
Délai: The time from enrollment to completion of intubation (usually within 10 minutes).
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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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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AI precision
Délai: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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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
Délai: 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
Délai: Video acquired from enrollment to completion of intubation, usually within 10 minutes.
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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)
Délai: 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.
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2026-0142
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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