- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07656155
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-KY-099
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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