Acute Respiratory Distress Syndrome (ARDS)
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Jee Hwan Ahn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days within 28 days | 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
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | From enrollment to Day 90 | All-cause mortality within 90 days after enrollment. |
| ICU mortality | From enrollment until ICU discharge, up to 90 days | Death occurring during the index ICU stay. |
| Hospital mortality | From enrollment until hospital discharge, up to 90 days | Death occurring during the index hospital admission. |
| Duration of invasive mechanical ventilation | From enrollment to Day 90 | Total number of days patients require invasive mechanical ventilation. |
| ICU length of stay | From enrollment until ICU discharge, up to 90 days | Total number of days spent in the ICU. |
| 28-day mortality | From enrollment to Day 28 | All-cause mortality within 28 days after enrollment. |
| Ventilator-associated pneumonia (VAP) | From enrollment until ICU discharge, up to 90 days | Incidence of VAP diagnosed according to standard clinical criteria during the index ICU stay. |
| Central line-associated bloodstream infection (CLABSI) | From enrollment until ICU discharge, up to 90 days | Incidence of CLABSI diagnosed according to CDC/NHSN criteria during the index ICU stay. |
| Barotrauma | 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. |
| Quality of life at hospital discharge | 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. |
| Disposition at hospital discharge | 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). |
| Hospital length of stay | From enrollment until hospital discharge, up to 90 days | Total number of days spent in the hospital. |
Countries
South Korea
Contacts
Primary ContactDirector, Medical Intensive Care Unit, Asan Medical Center
Backup ContactSu Yeon Lee, MD, PhD
Outcome results
None listed