Asan Medical Center
Seoul, 05505, South Korea
Location contact
Director, Medical Intensive Care Unit, Asan Medical Center
CONTACT
Jee Hwan Ahn, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07186140
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Seoul, 05505, South Korea
Director, Medical Intensive Care Unit, Asan Medical Center
CONTACT
Jee Hwan Ahn, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: From enrollment to Day 28
All-cause mortality within 28 days after enrollment.
Time frame: From enrollment to Day 90
All-cause mortality within 90 days after enrollment.
Time frame: From enrollment until ICU discharge, up to 90 days
Death occurring during the index ICU stay.
Time frame: From enrollment until hospital discharge, up to 90 days
Death occurring during the index hospital admission.
Time frame: From enrollment to Day 90
Total number of days patients require invasive mechanical ventilation.
Time frame: From enrollment until ICU discharge, up to 90 days
Total number of days spent in the ICU.
Time frame: From enrollment until hospital discharge, up to 90 days
Total number of days spent in the hospital.
Time frame: From enrollment until ICU discharge, up to 90 days
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
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
Incidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema documented by imaging or clinical assessment during the index ICU stay.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Director, Medical Intensive Care Unit, Asan Medical Center
CONTACT
Su Yeon Lee, MD, PhD
CONTACT
Jee Hwan Ahn
Other
A Prospective Cohort Study to Explore Clinical Features, Prognosis, and Therapeutic Strategies in Patients With Acute Respiratory Distress Syndrome
Acronym: ARDS-CTO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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