Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence
This project plans to employ a multi-center retrospective and prospective cohort study design. It aims to collect data on ventilator support strategies, duration of invasive mechanical ventilation, incidence of ventilator dependence, high-risk factors for ventilator dependence, and in-hospital mortality rates among different chronic disease populations in the ICU. This will involve combining unstructured data with real-time bedside multi-dimensional high-frequency data (including dynamic changes in data volume, respiratory mechanics, diaphragm ultrasound, EIT, diaphragm electrical activity, and other monitoring parameters) to construct digital phenotypes for chronic disease patients with ventilator dependence and identify high-risk factors for ventilator dependence in this population.
Specifically, the research will:
Utilize an integrated modular intelligent respiratory monitoring system, previously developed by the project team, to achieve dynamic monitoring of multi-dimensional indicators.
Systematically collect dynamic clinical characteristics of mechanical ventilation dependence in chronic disease populations through retrospective and prospective cohort studies, and employ multivariate statistical analysis, machine learning, and other techniques to identify no fewer than 5-6 high-risk factors for ventilator dependence in chronic disease patients.
Establish a data ecosystem suitable for chronic disease patients undergoing mechanical ventilation, build a multi-dimensional high-frequency data platform for chronic ventilator-dependent populations, map the full cycle from intubation to mechanical ventilation support, weaning, and extubation, and construct multidimensional digital phenotypes for high-risk chronic disease patients with ventilator dependence.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age > 18 years old.
- Patients admitted to ICU and receiving invasive mechanical ventilation.
- Comorbid with chronic diseases.
Exclusion Criteria:
- Total invasive mechanical ventilation duration ≤ 48 hours.
- Death within 7 days after ICU admission.
- Withdrawal of treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients in the Multicenter Retrospective Cohort
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Patients in the Multi-Center Prospective Cohort
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of ventilator dependence（mechanical ventilation time≥7 days） in chronic disease patients receiving invasive mechanical ventilation
Periodo de tiempo: From enrollment to 7 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.
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From enrollment to 7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
Periodo de tiempo: 21 days
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the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 14 and 21 days of the initial intubation.
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21 days
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Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Time to first extubation in chronic disease patients
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Proportion of first extubation failure in chronic disease patients
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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High-risk factors for first extubation failure in chronic disease patients
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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ICU mortality rate
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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In-hospital mortality rate
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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ICU length of stay
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Total hospital length of stay
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Duration of invasive mechanical ventilation
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Incidence of Ventilator-Associated Pneumonia (VAP)
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Proportion of patients undergoing tracheostomy
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Time of tracheostomy
Periodo de tiempo: during hospitalization，assessed up to 28 days
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among those who receive tracheostomy
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during hospitalization，assessed up to 28 days
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High-risk factors for ventilator dependence in chronic disease patients
Periodo de tiempo: during hospitalization，assessed up to 28 days
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during hospitalization，assessed up to 28 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-KY-099
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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