Invasive Mechanical Ventilation ARDSNCT05922826
Clinical Empirical Research of ARDS
An observational study of Invasive Mechanical Ventilation ARDS, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Invasive Mechanical Ventilation ARDS
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2023to 1 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.
Who may be able to join
- Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
- ARDS onset ≤ 3 days when included in the study
- Patient PaO2/FiO2 ≤ 200mmHg when included in the study
Who cannot join
- 1) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV
- 2) Age>85 years old or<18 years old
- 3) Pregnant patients
- 4) Severe hemodynamic instability (vasopressor increase>30% in the first 6 hours, or Norepinephrine>0.5 mg kg/min)
- 5) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)
- 6) Patients with abnormal esophageal anatomical structure and inability to indwelling gastric tubes
- 7) Disagreement for inclusion in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
lixin xie, doctor
About this study
According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.
- Conditions
- Invasive Mechanical Ventilation ARDS
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start18 Jun 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Mechanical Ventilation ARDSStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922826
- Sponsor's protocol ID
- ARDS Research
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duan Z, Lian D, Wang K, Hu Y, Fu H, Wen R, Zhao Y, Hu X, Pan P, Xu J, Chen J, Xiao L, Wang L, Yu X, Han X, Xie W, Xie F, Xie L, Han Z. Multi-modal data to identify key factors influencing lung injury in ARDS patients undergoing invasive mechanical ventilation: A prospective multi-center observational study protocol. PLoS One. 2026 Jan 23;21(1):e0332985. doi: 10.1371/journal.pone.0332985. eCollection 2026.
PubMed 41575959
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Empirical Research of ARDS
- ClinicalTrials.gov ID
- NCT05922826
- Acronym / sponsor ID
- ARDS Research
- Conditions
- Invasive Mechanical Ventilation ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 18 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Jun 2023 (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.
According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.
Key inclusion criteria (3 listed)
- Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
- ARDS onset ≤ 3 days when included in the study
- Patient PaO2/FiO2 ≤ 200mmHg when included in the study
Key exclusion criteria (7 listed)
- 1) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV
- 2) Age>85 years old or<18 years old
- 3) Pregnant patients
- 4) Severe hemodynamic instability (vasopressor increase>30% in the first 6 hours, or Norepinephrine>0.5 mg kg/min)
- 5) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)
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
Overall Survival
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 41575959Duan Z, Lian D, Wang K, Hu Y, Fu H, Wen R, Zhao Y, Hu X, Pan P, Xu J, Chen J, Xiao L, Wang L, Yu X, Han X, Xie W, Xie F, Xie L, Han Z. Multi-modal data to identify key factors influencing lung injury in ARDS patients undergoing invasive mechanical ventilation: A prospective multi-center observational study protocol. PLoS One. 2026 Jan 23;21(1):e0332985. doi: 10.1371/journal.pone.0332985. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Invasive Mechanical Ventilation ARDS
Not yet recruitingPhase 2/3
Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT
ARDS (Acute Respiratory Distress Syndrome), Invasive Mechanical Ventilation
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. This study is not recruiting at the moment.
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 Invasive Mechanical Ventilation ARDS, run by Chinese PLA General 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 7 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Wang, doctor (15822048750, wl1194079931@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922826, which also lists 1 linked publication.
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 28 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.