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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jintao Wei wei
- Número de teléfono: 19560480512
- Correo electrónico: weijintao@zju.edu.cn
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Reclutamiento
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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Contacto:
- Jintao Wei
- Número de teléfono: +86 19560480512
- Correo electrónico: weijintao@zju.edu.cn
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Shaoxing, Zhejiang, Porcelana, 312000
- Reclutamiento
- Shaoxing Central Hospital
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Contacto:
- dongzhi liu
- Correo electrónico: weijintao@zju.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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First-pass intubation success rate
Periodo de tiempo: 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).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intubation time
Periodo de tiempo: The time from enrollment to completion of intubation (usually within 10 minutes).
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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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-0142
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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