- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100029
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during hospitalization,assessed up to 28 days
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during hospitalization,assessed up to 28 days
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-KY-099
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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