Acute Respiratory Distress Syndrome (ARDS)NCT07445061
Machine Learning Prediction of Mortality After Prone Positioning in ARDS
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Prone Position Ventilation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Prone Position Ventilation, Machine Learning
- What is being tested?
- Prone Position Ventilation
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 1 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation in the intensive care unit at Zhongshan Hospital, Fudan University, between October 2019 and August 2025. Clinical data were retrospectively obtained from electronic medical records.
Who may be able to join
- Diagnosis of ARDS according to the Berlin definition;
- Receipt of at least one session of prone position ventilation (PPV) during hospitalization;
- Requirement for mechanical ventilation.
Who cannot join
- Age <18 years;
- PPV duration <6 hours;
- ICU length of stay <2 days;
- Pregnancy;
- Receipt of awake prone positioning.
- Missing key clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Machine Learning Model to Predict Mortality in Patients With Acute Respiratory Distress Syndrome After Prone Positioning
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Early identification of patients at high risk of mortality after PPV may improve clinical decision-making and individualized management.
This retrospective observational study developed and validated a machine learning model to predict intensive care unit (ICU) mortality in patients with ARDS receiving prone position ventilation. Clinical, laboratory, and treatment variables obtained from ICU electronic medical records were used to construct prediction models using multiple machine learning algorithms. The performance of these models was evaluated and compared to identify the optimal model for mortality prediction.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Prone Position Ventilation, Machine Learning, ICU, ARDS
- 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
Prone position ventilation applied as part of routine clinical care for patients with acute respiratory distress syndrome. No experimental intervention was assigned in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| ARDS Patients Receiving Prone Position Ventilation | Adult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation during intensive care unit (ICU) admission. Clinical data were retrospectively obtained from electronic medical records for the development and validation of machine learning models to predict ICU mortality. Receives: Other: Prone Position Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Death from any cause during the intensive care unit (ICU) stay among patients with acute respiratory distress syndrome receiving prone position ventilation.
Measured: Up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2026
- Study completion1 May 2026
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
- Retrospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445061
- Sponsor's protocol ID
- B2026-019
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the article will be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Model to Predict Mortality in Patients With Acute Respiratory Distress Syndrome After Prone Positioning
- ClinicalTrials.gov ID
- NCT07445061
- Acronym / sponsor ID
- B2026-019
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Prone Position Ventilation, Machine Learning, ICU, ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 3 Mar 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.
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Early identification of patients at high risk of mortality after PPV may improve clinical decision-making and individualized management.
This retrospective observational study developed and validated a machine learning model to predict intensive care unit (ICU) mortality in patients with ARDS receiving prone position ventilation. Clinical, laboratory, and treatment variables obtained from ICU electronic medical records were used to construct prediction models using multiple machine learning algorithms. The performance of these models was evaluated and compared to identify the optimal model for mortality prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS Patients Receiving Prone Position Ventilation | – | Other: Prone Position VentilationAdult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation during intensive care unit (ICU) admission. Clinical data were retrospectively obtained from electronic medical records for the development and validation of machine learning models to predict ICU mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with acute respiratory distress syndrome (ARDS) who received prone position ventilation in the intensive care unit at Zhongshan Hospital, Fudan University, between October 2019 and August 2025. Clinical data were retrospectively obtained from electronic medical records.
Key inclusion criteria (3 listed)
- Diagnosis of ARDS according to the Berlin definition;
- Receipt of at least one session of prone position ventilation (PPV) during hospitalization;
- Requirement for mechanical ventilation.
Key exclusion criteria (6 listed)
- Age <18 years;
- PPV duration <6 hours;
- ICU length of stay <2 days;
- Pregnancy;
- Receipt of awake prone positioning.
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 VentilationProne position ventilation applied as part of routine clinical care for patients with acute respiratory distress syndrome. No experimental intervention was assigned in this observational study. | Other | ARDS Patients Receiving Prone Position Ventilation |
Primary outcome
ICU Mortality
Time frame: Up to 90 days.
Death from any cause during the intensive care unit (ICU) stay among patients with acute respiratory distress syndrome receiving prone position ventilation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the article will be available from the corresponding author upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (ARDS) and Prone Position Ventilation, run by Shanghai Zhongshan 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 6 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICU Mortality (time frame: Up to 90 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 14 Aug 2026.