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NCT Number: NCT07186140

Clinical Features, Treatments, and Outcomes in Acute Respiratory Distress Syndrome (ARDS-CTO)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Location contact

Director, Medical Intensive Care Unit, Asan Medical Center

CONTACT

[email protected]

82-2-3010-3130

Jee Hwan Ahn, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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.

Exclusion criteria

  • 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.
  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 28-day mortality

    Time frame: From enrollment to Day 28

    All-cause mortality within 28 days after enrollment.

  2. 90-day mortality

    Time frame: From enrollment to Day 90

    All-cause mortality within 90 days after enrollment.

  3. ICU mortality

    Time frame: From enrollment until ICU discharge, up to 90 days

    Death occurring during the index ICU stay.

  4. Hospital mortality

    Time frame: From enrollment until hospital discharge, up to 90 days

    Death occurring during the index hospital admission.

  5. Duration of invasive mechanical ventilation

    Time frame: From enrollment to Day 90

    Total number of days patients require invasive mechanical ventilation.

  6. ICU length of stay

    Time frame: From enrollment until ICU discharge, up to 90 days

    Total number of days spent in the ICU.

  7. Hospital length of stay

    Time frame: From enrollment until hospital discharge, up to 90 days

    Total number of days spent in the hospital.

  8. Ventilator-associated pneumonia (VAP)

    Time frame: From enrollment until ICU discharge, up to 90 days

    Incidence of VAP diagnosed according to standard clinical criteria during the index ICU stay.

  9. Central line-associated bloodstream infection (CLABSI)

    Time frame: From enrollment until ICU discharge, up to 90 days

    Incidence of CLABSI diagnosed according to CDC/NHSN criteria during the index ICU stay.

  10. Barotrauma

    Time frame: From enrollment until ICU discharge, up to 90 days

    Incidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema documented by imaging or clinical assessment during the index ICU stay.

  11. Quality of life at hospital discharge

    Time frame: From enrollment until hospital discharge, up to 90 days

    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.

  12. Disposition at hospital discharge

    Time frame: From enrollment until hospital discharge, up to 90 days

    Patient's destination at hospital discharge (e.g., home, rehabilitation, long-term care facility, or death).

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Medical Intensive Care Unit, Asan Medical Center

CONTACT

[email protected]

82-2-3010-3130

Su Yeon Lee, MD, PhD

CONTACT

[email protected]

82-2-3010-6809

Sponsors and collaborators

Lead sponsor

Jee Hwan Ahn

Other

Registry information

Official study title

A Prospective Cohort Study to Explore Clinical Features, Prognosis, and Therapeutic Strategies in Patients With Acute Respiratory Distress Syndrome

Acronym: ARDS-CTO

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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