Status:
NOT_YET_RECRUITING
Clinical Features, Treatments, and Outcomes in Acute Respiratory Distress Syndrome (ARDS-CTO)
Lead Sponsor:
Jee Hwan Ahn
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
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)...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT07186140
Start Date
October 1 2025
End Date
December 1 2035
Last Update
September 22 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505