Acute Respiratory Distress Syndrome (ARDS)NCT06967207
Electrical Impedance Tomography-Based Prognostic Model for ARDS
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Ventilator-induced Lung Injury, run by XiaoJing Zou,MD at 4 sites in China.
Trial summary
This multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Ventilator-induced Lung Injury
- What is being tested?
- Not applicable- observational study
- How many people
- 625 participants
- Where
- 4 sitesChina
- Study dates
- 15 Apr 2025to 31 Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, multicenter, observational cohort study that will enroll adult patients (aged 18-80 years) diagnosed with acute respiratory distress syndrome (ARDS) per the new 2023 ARDS global definition.
Who may be able to join
- Meet the new 2023 ARDS global definition;
- Age 18-80 years
Who cannot join
- Expected death within 24 hours of screening;
- Metastatic cancer (active malignancy with distant metastases);
- Severe psychiatric disorders;
- Pregnancy or postpartum status;
- Pneumothorax or moderate to large pleural effusion without adequate drainage;
- Chronic respiratory failure;
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- Patients with pulmonary embolism or pulmonary hypertension;
- Heart failure patients: EF <50% or NYHA class III or IV;
- Patient/family refusal to participate;
- Participation in another interventional trial within 3 months prior to enrollment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Department of Critical Care Medicine, Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yiyu Deng, 86+15013287340, dengyiyu@gdph.org.cn
- Recruiting
Department of Emergency, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Zhenju Song, 86+13816607453, song.zhenju@zs-hospital.sh.cn
- Recruiting
Department of Critical Care Medicine, Renmin Hospital of Wuhan University
Wuhan, Hubei
Liying Zhan, +8615327408448, zhanliying@whu.edu.cn
- Recruiting
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China Department of
Wuhan, Hubei
Xiaojing Zou, 86+13995518630, 249126734@qq.com
About this study
Official title: Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study
This multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.
- Being tested
- Not applicable- observational study
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| ARDS Patients for Training cohort | Training cohort Receives: Other: Not applicable- observational study | |
| ARDS Patients for Validation cohort | Validation cohort Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality rate
Measured: From date of study enrollment (Day 0) until Day 28
Secondary outcomes (7)
ICU mortality rate
Measured: From ICU admission to discharge, up to 24 weeks
60-day all-cause mortality rate
Measured: 60 days post-enrollment
90-day all-cause mortality rate
Measured: 90 days post-enrollment
Duration of mechanical ventilation (days)
Measured: From intubation to successful extubation, up to 28 days
Ventilator-free days (VFDs) at 28 days
Measured: 28 days post-enrollment
ICU length of stay (days)
Measured: From ICU admission to discharge, up to 24 weeks
Hospital length of stay
Measured: From hospital admission to discharge, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XiaoJing Zou,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoJing Zou,MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967207
- Sponsor's protocol ID
- EIT20250331
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography-Based Prognostic Model for ARDS: A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06967207
- Acronym / sponsor ID
- EIT20250331
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- XiaoJing Zou,MDUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2025 (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 multicenter, prospective, observational study aims to develop and validate an EIT-based prognostic model for ARDS. By focusing on the pathophysiological characteristics of ARDS and the causes of ventilator-induced lung injury, the investigators intend to establish a prognostic model that reveals lung injury and heterogeneity, enabling risk stratification and guiding individualized treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS Patients for Training cohort | – | Other: Not applicable- observational studyTraining cohort |
| ARDS Patients for Validation cohort | – | Other: Not applicable- observational studyValidation cohort |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, multicenter, observational cohort study that will enroll adult patients (aged 18-80 years) diagnosed with acute respiratory distress syndrome (ARDS) per the new 2023 ARDS global definition.
Key inclusion criteria (2 listed)
- Meet the new 2023 ARDS global definition;
- Age 18-80 years
Key exclusion criteria (10 listed)
- Expected death within 24 hours of screening;
- Metastatic cancer (active malignancy with distant metastases);
- Severe psychiatric disorders;
- Pregnancy or postpartum status;
- Pneumothorax or moderate to large pleural effusion without adequate drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | ARDS Patients for Training cohort, ARDS Patients for Validation cohort |
Primary outcome
28-day mortality rate
Time frame: From date of study enrollment (Day 0) until Day 28
7 secondary outcomes
ICU mortality rate
Time frame: From ICU admission to discharge, up to 24 weeks
60-day all-cause mortality rate
Time frame: 60 days post-enrollment
90-day all-cause mortality rate
Time frame: 90 days post-enrollment
Duration of mechanical ventilation (days)
Time frame: From intubation to successful extubation, up to 28 days
Ventilator-free days (VFDs) at 28 days
Time frame: 28 days post-enrollment
ICU length of stay (days)
Time frame: From ICU admission to discharge, up to 24 weeks
Hospital length of stay
Time frame: From hospital admission to discharge, up to 24 weeks
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 13 May 2025.
- Individual participant dataSharing planned: Yes
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Ventilator-induced Lung Injury, run by XiaoJing Zou,MD at 4 sites 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Xiaojing Zou Zou (84+13995518630, 249126734@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality rate (time frame: From date of study enrollment (Day 0) until Day 28). 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 13 May 2025.