- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-KY-099
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Informazioni su farmaci e dispositivi, documenti di studio
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