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

N/ANot Yet RecruitingNCT07186140

Jee Hwan Ahn800 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

800

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to Day 28

Secondary Outcomes

28-day mortality

All-cause mortality within 28 days after enrollment.

Time frame: From enrollment to Day 28

90-day mortality

All-cause mortality within 90 days after enrollment.

Time frame: From enrollment to Day 90

ICU mortality

Death occurring during the index ICU stay.

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

Hospital mortality

Death occurring during the index hospital admission.

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

Duration of invasive mechanical ventilation

Total number of days patients require invasive mechanical ventilation.

Time frame: From enrollment to Day 90

ICU length of stay

Total number of days spent in the ICU.

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

Hospital length of stay

Total number of days spent in the hospital.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

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

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts