Acute Respiratory Distress Syndrome (ARDS)ARDS-CTONCT07186140
Clinical Features, Treatments, and Outcomes in Acute Respiratory Distress Syndrome (ARDS-CTO)
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Jee Hwan Ahn at 1 site in South Korea.
Trial summary
The goal of this observational prospective cohort study is to explore the clinical characteristics, treatment strategies, and outcomes of adult patients with acute respiratory distress syndrome (ARDS) admitted to the medical intensive care unit of Asan Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2025to Dec 2035
- How long will I take part?
- 90 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: This study will enroll participants from among patients with acute respiratory failure who are admitted to the medical intensive care unit of Asan Medical Center in Seoul, Korea.
Who may be able to join
- Age ≥ 18 years.
- Receiving respiratory support with one of the following:
- High-flow nasal oxygen (HFNO) at a flow rate ≥ 30 L/min,
- Noninvasive ventilation (NIV) with positive end-expiratory pressure (PEEP) of ≥ 5 cm H₂O, or
- Invasive mechanical ventilation with PEEP of ≥ 5 cm H₂O.
- Within 48 hours before or after eligibility screening, the following criteria must be met:
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- PaO₂/FiO₂ ≤ 300 mmHg under the above respiratory support.
- Bilateral opacities on chest radiograph or computed tomography, not fully explained by effusions, lobar/lung collapse (atelectasis), or pulmonary nodules/masses.
- Respiratory failure not fully explained by cardiac failure or fluid overload; when no clear ARDS risk factor is identified, an objective assessment (e.g., echocardiography) is required to exclude hydrostatic edema.
Who cannot join
- Refusal of informed consent by the patient or a legally authorized representative.
- Chronic respiratory failure, defined as:
- Patients receiving long-term oxygen therapy or home mechanical ventilation (except for CPAP used solely for obstructive sleep apnea), or
- Outpatients with PaCO₂ > 60 mmHg.
- Diffuse alveolar hemorrhage.
- Interstitial lung disease.
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- Moribund patients expected to survive < 24 hours.
- Patients expected to require high-flow nasal oxygen or mechanical ventilation for < 48 hours.
- Patients with a decision to withhold life-sustaining treatment (except those for whom full support is provided other than cardiopulmonary resuscitation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Director, Medical Intensive Care Unit, Asan Medical Center contact
South Korea1 site
Asan Medical Center
Seoul, 05505
Director, Medical Intensive Care Unit, Asan Medical Center, 82-2-3010-3130, ggaamang24@amc.seoul.kr
Jee Hwan Ahn, MD, PhD
About this study
Official title: A Prospective Cohort Study to Explore Clinical Features, Prognosis, and Therapeutic Strategies in Patients With Acute Respiratory Distress Syndrome
The goal of this observational prospective cohort study is to explore the clinical characteristics, treatment strategies, and outcomes of adult patients with acute respiratory distress syndrome (ARDS) admitted to the medical intensive care unit of Asan Medical Center. The main questions it aims to answer are:
- What are the clinical features, current practices, and prognosis of ARDS patients in Korea?
- How do different mechanical ventilation settings affect ARDS patient outcomes?
Read more
Participants will:
- Be screened at medical ICU admission for eligibility according to the Berlin definition of ARDS.
- Have demographic, clinical, laboratory, and ventilator data collected from bedside monitoring devices and electronic health records during their ICU stay.
- Complete a quality-of-life questionnaire (EQ-5D) at hospital discharge if they survive.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute respiratory distress syndrome (ARDS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days within 28 days
Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment. Patients who die within 28 days will be assigned zero ventilator-free days.
Measured: From enrollment to Day 28
Secondary outcomes (12)
28-day mortality
All-cause mortality within 28 days after enrollment.
Measured: From enrollment to Day 28
90-day mortality
All-cause mortality within 90 days after enrollment.
Measured: From enrollment to Day 90
ICU mortality
Death occurring during the index ICU stay.
Measured: From enrollment until ICU discharge, up to 90 days
Hospital mortality
Death occurring during the index hospital admission.
Measured: From enrollment until hospital discharge, up to 90 days
Duration of invasive mechanical ventilation
Total number of days patients require invasive mechanical ventilation.
Measured: From enrollment to Day 90
ICU length of stay
Total number of days spent in the ICU.
Measured: From enrollment until ICU discharge, up to 90 days
Hospital length of stay
Total number of days spent in the hospital.
Measured: From enrollment until hospital discharge, up to 90 days
Ventilator-associated pneumonia (VAP)
Incidence of VAP diagnosed according to standard clinical criteria during the index ICU stay.
Measured: From enrollment until ICU discharge, up to 90 days
Central line-associated bloodstream infection (CLABSI)
Incidence of CLABSI diagnosed according to CDC/NHSN criteria during the index ICU stay.
Measured: From enrollment until ICU discharge, up to 90 days
Barotrauma
Incidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema documented by imaging or clinical assessment during the index ICU stay.
Measured: From enrollment until ICU discharge, up to 90 days
Quality of life at hospital discharge
Health-related quality of life assessed using the 5-level European Quality of Life 5 Dimensions version (EQ-5D-5L) questionnaire at the time of hospital discharge for survivors. Scores range from -0.066 to 1.0 (based on Korean Time Trade-Off value set), with higher scores indicating better health status.
Measured: From enrollment until hospital discharge, up to 90 days
Disposition at hospital discharge
Patient's destination at hospital discharge (e.g., home, rehabilitation, long-term care facility, or death).
Measured: From enrollment until hospital discharge, 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 posted22 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (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
- 800 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Jee Hwan Ahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jee Hwan Ahn, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186140
- Sponsor's protocol ID
- 2025-0891
- Acronym
- ARDS-CTO
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Explore Clinical Features, Prognosis, and Therapeutic Strategies in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07186140
- Acronym / sponsor ID
- ARDS-CTO / 2025-0891
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jee Hwan AhnUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 22 Sep 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.
The goal of this observational prospective cohort study is to explore the clinical characteristics, treatment strategies, and outcomes of adult patients with acute respiratory distress syndrome (ARDS) admitted to the medical intensive care unit of Asan Medical Center. The main questions it aims to answer are:
- What are the clinical features, current practices, and prognosis of ARDS patients in Korea?
- How do different mechanical ventilation settings affect ARDS patient outcomes?
Participants will:
- Be screened at medical ICU admission for eligibility according to the Berlin definition of ARDS.
- Have demographic, clinical, laboratory, and ventilator data collected from bedside monitoring devices and electronic health records during their ICU stay.
- Complete a quality-of-life questionnaire (EQ-5D) at hospital discharge if they survive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute respiratory distress syndrome (ARDS) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll participants from among patients with acute respiratory failure who are admitted to the medical intensive care unit of Asan Medical Center in Seoul, Korea.
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Receiving respiratory support with one of the following:
- High-flow nasal oxygen (HFNO) at a flow rate ≥ 30 L/min,
- Noninvasive ventilation (NIV) with positive end-expiratory pressure (PEEP) of ≥ 5 cm H₂O, or
- Invasive mechanical ventilation with PEEP of ≥ 5 cm H₂O.
Key exclusion criteria (9 listed)
- Refusal of informed consent by the patient or a legally authorized representative.
- Chronic respiratory failure, defined as:
- Patients receiving long-term oxygen therapy or home mechanical ventilation (except for CPAP used solely for obstructive sleep apnea), or
- Outpatients with PaCO₂ > 60 mmHg.
- Diffuse alveolar hemorrhage.
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
Ventilator-free days within 28 days
Time frame: From enrollment to Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after enrollment. Patients who die within 28 days will be assigned zero ventilator-free days.
12 secondary outcomes
28-day mortality
Time frame: From enrollment to Day 28
90-day mortality
Time frame: From enrollment to Day 90
ICU mortality
Time frame: From enrollment until ICU discharge, up to 90 days
Hospital mortality
Time frame: From enrollment until hospital discharge, up to 90 days
Duration of invasive mechanical ventilation
Time frame: From enrollment to Day 90
ICU length of stay
Time frame: From enrollment until ICU discharge, up to 90 days
Hospital length of stay
Time frame: From enrollment until hospital discharge, up to 90 days
Ventilator-associated pneumonia (VAP)
Time frame: From enrollment until ICU discharge, up to 90 days
Central line-associated bloodstream infection (CLABSI)
Time frame: From enrollment until ICU discharge, up to 90 days
Barotrauma
Time frame: From enrollment until ICU discharge, up to 90 days
Quality of life at hospital discharge
Time frame: From enrollment until hospital discharge, up to 90 days
Disposition at hospital discharge
Time frame: From enrollment until hospital discharge, up to 90 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 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Director, Medical Intensive Care Unit, Asan Medical Center contact
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), run by Jee Hwan Ahn at 1 site in South Korea.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Sep 2025. 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 South Korea. 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 Director, Medical Intensive Care Unit, Asan Medical Center (82-2-3010-3130, ggaamang24@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days within 28 days (time frame: From enrollment to 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 22 Sep 2025.