Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients

NCT07656155 | Enrolling By Invitation DMC

• 1 other identifier: 2025-KY-099
• Study Type: observational
• Target: 30,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator Dependency

Keywords

Ventilator Dependence; Chronic Disease; Mechanical Ventilation; Intensive Care Units; Risk Factors; Digital Phenotyping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Proportion of chronic disease patients still receiving IPPV at 14/21 days after mechanical ventilation

  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

Study Arms (2)

Patients in the Multicenter Retrospective Cohort

Patients in the Multi-Center Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological Sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Disease Patients with invasive mechanical ventilation ≥48 hours

You may qualify if:

• Age \> 18 years old.
• Patients admitted to ICU and receiving invasive mechanical ventilation.
• Comorbid with chronic diseases.

You may not qualify if:

• Total invasive mechanical ventilation duration ≤ 48 hours.
• Death within 7 days after ICU admission.
• Withdrawal of treatment.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Zhongda Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd: collaborator

Study Sites (1)

Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xu Huang, MD

  Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)