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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ventilator Dependency

• Study Type: Observational
• Enrollment (Estimated): 30500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic Disease Patients with invasive mechanical ventilation ≥48 hours

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients in the Multicenter Retrospective Cohort
Patients in the Multi-Center Prospective Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ventilator dependence（mechanical ventilation time≥7 days） in chronic disease patients receiving invasive mechanical ventilation	the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.	From enrollment to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation	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		during hospitalization，assessed up to 28 days
Time to first extubation in chronic disease patients		during hospitalization，assessed up to 28 days
Proportion of first extubation failure in chronic disease patients		during hospitalization，assessed up to 28 days
High-risk factors for first extubation failure in chronic disease patients		during hospitalization，assessed up to 28 days
ICU mortality rate		during hospitalization，assessed up to 28 days
In-hospital mortality rate		during hospitalization，assessed up to 28 days
ICU length of stay		during hospitalization，assessed up to 28 days
Total hospital length of stay		during hospitalization，assessed up to 28 days
Duration of invasive mechanical ventilation		during hospitalization，assessed up to 28 days
Incidence of Ventilator-Associated Pneumonia (VAP)		during hospitalization，assessed up to 28 days
Proportion of patients undergoing tracheostomy		during hospitalization，assessed up to 28 days
Time of tracheostomy	among those who receive tracheostomy	during hospitalization，assessed up to 28 days
High-risk factors for ventilator dependence in chronic disease patients		during hospitalization，assessed up to 28 days

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Zhongda Hospital; First Affiliated Hospital of Chongqing Medical University; Shenzhen Mindray Bio-Medical Electronics Co., Ltd
• Investigators: Principal Investigator: Xu Huang, MD, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Risk Factors; Mechanical Ventilation; Intensive Care Units; Chronic Disease; Digital Phenotyping; Ventilator Dependence
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease
• Other Study ID Numbers: 2025-KY-099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No