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

NCT07186140 | Not Yet Recruiting

• 1 other identifier: 2025-0891
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to Day 28

Secondary Outcomes (12)

• 28-day mortality

  From enrollment to Day 28

• 90-day mortality

  From enrollment to Day 90

• ICU mortality

  From enrollment until ICU discharge, up to 90 days

• Hospital mortality

  From enrollment until hospital discharge, up to 90 days

• Duration of invasive mechanical ventilation

  From enrollment to Day 90

Study Arms (1)

Acute respiratory distress syndrome (ARDS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jee Hwan Ahn: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Director, Medical Intensive Care Unit, Asan Medical Center

CONTACT

82-2-3010-3130; ggaamang24@amc.seoul.kr

Su Yeon Lee, MD, PhD

CONTACT

82-2-3010-6809; lsy5013@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, University of Ulsan College of Medicine; Director, Medical ICU, Asan Medical Center

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

KR (1)