Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07656155

Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of ventilator dependence(mechanical ventilation time≥7 days) in chronic disease patients receiving invasive mechanical ventilation

    Time frame: From enrollment to 7 days

    the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 7 days of the initial intubation.

Secondary outcomes

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

    Time frame: 21 days

    the proportion of patients who achieve sustained liberation from invasive mechanical ventilation within 14 and 21 days of the initial intubation.

  2. Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients

    Time frame: during hospitalization,assessed up to 28 days

  3. Time to first extubation in chronic disease patients

    Time frame: during hospitalization,assessed up to 28 days

  4. Proportion of first extubation failure in chronic disease patients

    Time frame: during hospitalization,assessed up to 28 days

  5. High-risk factors for first extubation failure in chronic disease patients

    Time frame: during hospitalization,assessed up to 28 days

  6. ICU mortality rate

    Time frame: during hospitalization,assessed up to 28 days

  7. In-hospital mortality rate

    Time frame: during hospitalization,assessed up to 28 days

  8. ICU length of stay

    Time frame: during hospitalization,assessed up to 28 days

  9. Total hospital length of stay

    Time frame: during hospitalization,assessed up to 28 days

  10. Duration of invasive mechanical ventilation

    Time frame: during hospitalization,assessed up to 28 days

  11. Incidence of Ventilator-Associated Pneumonia (VAP)

    Time frame: during hospitalization,assessed up to 28 days

  12. Proportion of patients undergoing tracheostomy

    Time frame: during hospitalization,assessed up to 28 days

  13. Time of tracheostomy

    Time frame: during hospitalization,assessed up to 28 days

    among those who receive tracheostomy

  14. High-risk factors for ventilator dependence in chronic disease patients

    Time frame: during hospitalization,assessed up to 28 days

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • First Affiliated Hospital of Chongqing Medical University
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd
  • Zhongda Hospital

Registry information

Official study title

Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.