Acute Respiratory Distress SyndromePPV SAFENCT07284888
Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study
An observational study of Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Prone position ventilation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Jan 2029
- How long will I take part?
- 60 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: Moderate-to-severe ARDS
Who may be able to join
- 1.Age ≥ 18 years 2. Moderate-to-severe ARDS requiring invasive mechanical ventilation, defined as:
- PaO₂/FiO₂ ≤ 150 mm Hg,
- PEEP ≥ 5 cm H₂O,
- ARDS diagnosed according to the 2023 Global Definition.
Who cannot join
- 1.Refusal of informed consent by the patient's legally authorized representative
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, 1 recruiting
- Recruiting
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Hui Chen, +86-18006138640, 15905162429@163.com
About this study
Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure.
Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Prone position ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position ventilationOther
Patients underwent prone positioning while receiving invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients received PPV | Not described Receives: Other: Prone position ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day mortality
The proportion of patients who are died within 60 days
Measured: From inclusion to 28 days
Secondary outcomes (2)
28-day mortality
The proportion of patients who are died within 28 days
Measured: From inclusion to 28 days
Ventilator-free days at 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Measured: From inclusion 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 posted16 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (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 SyndromeStudies 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
- 1,000 participants (estimated)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284888
- Sponsor's protocol ID
- PPV in ARDS
- Acronym
- PPV SAFE
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study
- ClinicalTrials.gov ID
- NCT07284888
- Acronym / sponsor ID
- PPV SAFE / PPV in ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 16 Dec 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.
Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure.
Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients received PPV | – | Other: Prone position ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate-to-severe ARDS
Key inclusion criteria (4 listed)
- 1.Age ≥ 18 years 2. Moderate-to-severe ARDS requiring invasive mechanical ventilation, defined as:
- PaO₂/FiO₂ ≤ 150 mm Hg,
- PEEP ≥ 5 cm H₂O,
- ARDS diagnosed according to the 2023 Global Definition.
Key exclusion criteria (1 listed)
- 1.Refusal of informed consent by the patient's legally authorized representative
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 |
|---|---|---|
| Prone position ventilationPatients underwent prone positioning while receiving invasive mechanical ventilation | Other | ARDS patients received PPV |
Primary outcome
60-day mortality
Time frame: From inclusion to 28 days
The proportion of patients who are died within 60 days
2 secondary outcomes
28-day mortality
Time frame: From inclusion to 28 days
Ventilator-free days at 28 days
Time frame: From inclusion 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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
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 Acute Respiratory Distress Syndrome, run by Southeast University, China 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 4 inclusion and 1 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 2 Jan 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?
Contact Hui Chen, MD (+8618006138640, huichen.icu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day mortality (time frame: From inclusion to 28 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 2 Jan 2026.