Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventilator Dependency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence
Overview
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.
Primary outcome measures
- Proportion of ventilator dependence（mechanical ventilation time≥7 days） in chronic disease patients receiving invasive mechanical ventilation [Time frame: From enrollment to 7 days]
Secondary outcome measures (12)
- Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation [Time frame: 21 days]
- Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients [Time frame: during hospitalization，assessed up to 28 days]
- Time to first extubation in chronic disease patients [Time frame: during hospitalization，assessed up to 28 days]
- Proportion of first extubation failure in chronic disease patients [Time frame: during hospitalization，assessed up to 28 days]
- High-risk factors for first extubation failure in chronic disease patients [Time frame: during hospitalization，assessed up to 28 days]
- ICU mortality rate [Time frame: during hospitalization，assessed up to 28 days]
- In-hospital mortality rate [Time frame: during hospitalization，assessed up to 28 days]
- ICU length of stay [Time frame: during hospitalization，assessed up to 28 days]
- Total hospital length of stay [Time frame: during hospitalization，assessed up to 28 days]
- Duration of invasive mechanical ventilation [Time frame: during hospitalization，assessed up to 28 days]
- Incidence of Ventilator-Associated Pneumonia (VAP) [Time frame: during hospitalization，assessed up to 28 days]
- Proportion of patients undergoing tracheostomy [Time frame: during hospitalization，assessed up to 28 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- — Beijing
Identifiers
NCT: NCT07656155 · 2025-KY-099