Ventilator DependencyNCT07656155
Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
An observational study of Ventilator Dependency, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Dependency
- How many people
- 30,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to Jan 2029
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Disease Patients with invasive mechanical ventilation ≥48 hours
Who may be able to join
- Age > 18 years old.
- Patients admitted to ICU and receiving invasive mechanical ventilation.
- Comorbid with chronic diseases.
Who cannot join
- Total invasive mechanical ventilation duration ≤ 48 hours.
- Death within 7 days after ICU admission.
- Withdrawal of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: 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:
Read more
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
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the Multicenter Retrospective Cohort | Not described | |
| Patients in the Multi-Center Prospective Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 7 days
Secondary outcomes (14)
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.
Measured: 21 days
Success rate of the first Spontaneous Breathing Trial (SBT) in chronic disease patients
Measured: during hospitalization，assessed up to 28 days
Time to first extubation in chronic disease patients
Measured: during hospitalization，assessed up to 28 days
Proportion of first extubation failure in chronic disease patients
Measured: during hospitalization，assessed up to 28 days
High-risk factors for first extubation failure in chronic disease patients
Measured: during hospitalization，assessed up to 28 days
ICU mortality rate
Measured: during hospitalization，assessed up to 28 days
In-hospital mortality rate
Measured: during hospitalization，assessed up to 28 days
ICU length of stay
Measured: during hospitalization，assessed up to 28 days
Total hospital length of stay
Measured: during hospitalization，assessed up to 28 days
Duration of invasive mechanical ventilation
Measured: during hospitalization，assessed up to 28 days
Incidence of Ventilator-Associated Pneumonia (VAP)
Measured: during hospitalization，assessed up to 28 days
Proportion of patients undergoing tracheostomy
Measured: during hospitalization，assessed up to 28 days
Time of tracheostomy
among those who receive tracheostomy
Measured: during hospitalization，assessed up to 28 days
High-risk factors for ventilator dependence in chronic disease patients
Measured: during hospitalization，assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator DependencyStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30,500 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital, First Affiliated Hospital of Chongqing Medical University, Shenzhen Mindray Bio-Medical Electronics Co., Ltd
- Responsible party
- Principal investigator, Huang Xu, China-Japan Friendship Hospital
- Investigators
- Xu Huang, MD, Principal investigator, Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656155
- Sponsor's protocol ID
- 2025-KY-099
- Status last verified
- Apr 2026
- First submitted
- 21 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Digital Phenotyping of High-Risk Chronic Disease Patients With Ventilator Dependence
- ClinicalTrials.gov ID
- NCT07656155
- Acronym / sponsor ID
- 2025-KY-099
- Conditions
- Ventilator Dependency
- Keywords
- Ventilator Dependence, Chronic Disease, Mechanical Ventilation, Intensive Care Units, Risk Factors, Digital Phenotyping
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30,500 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Zhongda Hospital, First Affiliated Hospital of Chongqing Medical University, Shenzhen Mindray Bio-Medical Electronics Co., Ltd
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the Multicenter Retrospective Cohort | – | – |
| Patients in the Multi-Center Prospective Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Disease Patients with invasive mechanical ventilation ≥48 hours
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Patients admitted to ICU and receiving invasive mechanical ventilation.
- Comorbid with chronic diseases.
Key exclusion criteria (3 listed)
- Total invasive mechanical ventilation duration ≤ 48 hours.
- Death within 7 days after ICU admission.
- Withdrawal of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
14 secondary outcomes
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
Time of tracheostomy
Time frame: during hospitalization，assessed up to 28 days
High-risk factors for ventilator dependence in chronic disease patients
Time frame: during hospitalization，assessed up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xu Huang, MD principal investigator
Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Dependency, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ventilator dependence（mechanical ventilation time≥7 days） in chronic disease patients receiving invasive mechanical ventilation (time frame: From enrollment to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.