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Not yet recruiting NCT07186140

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

— Observational Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Primary outcome measures

  • Ventilator-free days within 28 days [Time frame: From enrollment to Day 28]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT07186140 · 2025-0891

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗