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Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients

14. juni 2026 opdateret af: Huang Xu, China-Japan Friendship Hospital

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

Tilmelding efter invitation

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Chronic Disease Patients with invasive mechanical ventilation ≥48 hours

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients in the Multicenter Retrospective Cohort
Patients in the Multi-Center Prospective Cohort

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation
Tidsramme: From enrollment to 7 days
the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.
From enrollment to 7 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation
Tidsramme: 21 days
the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 14 and 21 days of the initial intubation.
21 days
Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Time to first extubation in chronic disease patients
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Proportion of first extubation failure in chronic disease patients
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
High-risk factors for first extubation failure in chronic disease patients
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
ICU mortality rate
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
In-hospital mortality rate
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
ICU length of stay
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Total hospital length of stay
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Duration of invasive mechanical ventilation
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Incidence of Ventilator-Associated Pneumonia (VAP)
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Proportion of patients undergoing tracheostomy
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days
Time of tracheostomy
Tidsramme: during hospitalization,assessed up to 28 days
among those who receive tracheostomy
during hospitalization,assessed up to 28 days
High-risk factors for ventilator dependence in chronic disease patients
Tidsramme: during hospitalization,assessed up to 28 days
during hospitalization,assessed up to 28 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ventilator afhængighed

3
Abonner