Acute Respiratory FailureNCT06479421
A Clinical Study for Developing Artificial Intelligence(AI)-Based Clustering Model for Personalized Medicine in Acute Respiratory Failure
An observational study of Acute Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2023to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with acute respiratory failure admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure. 2. The following patients (control group) admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment
Who may be able to join
None listed.
Who cannot join
- If any of the following criteria applies, participants will not be permitted to participate in this clinical trial.
- Patients 48 hours after oxygen treatment (HFNC, NIV (BIPAP or CPAP), MV)
- Patients transferred from another hospital
- Patients with limitations in treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam, 06351
Hye Rim Chung, +82-2-3410-6399, hyerim37.jeong@samsung.com
About this study
Official title: A Clinical Study for Developing AI-based Clustering Model for Personalized Medicine in Acute Respiratory Failure: Single Center, Prospective Cohort Study
The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.
- Conditions
- Acute Respiratory Failure
- Keywords
- phenotyping, clustering analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Failure group | Among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital, if all of the following conditions are met: 1. Age 18 or older 2. Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure. | |
| Control group | For comparative analysis, among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital who meet all of the following conditions, they are registered as a control group with the consent of the subjects and undergo the same research procedure. 1. Age 18 or older 2. Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
clinical outcomes - Hospital Mortality
Measured: From date of admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year
Secondary outcomes (3)
ICU Mortality
clinical outcomes - ICU Mortality
Measured: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 6 months
Hospital length of stay
clinical outcomes - Hospital length of stay
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 1 years
ICU length of stay
clinical outcomes - ICU length of stay
Measured: From date of ICU admission until the date of ICU discharge, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start14 Aug 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Principal investigator, Ryoung-Eun Ko, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479421
- Sponsor's protocol ID
- 2023-08-003
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Developing AI-based Clustering Model for Personalized Medicine in Acute Respiratory Failure: Single Center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06479421
- Acronym / sponsor ID
- 2023-08-003
- Conditions
- Acute Respiratory Failure
- Keywords
- phenotyping, clustering analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Failure group | – | –Among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital, if all of the following conditions are met: 1. Age 18 or older 2. Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure. |
| Control group | – | –For comparative analysis, among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital who meet all of the following conditions, they are registered as a control group with the consent of the subjects and undergo the same research procedure. 1. Age 18 or older 2. Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with acute respiratory failure admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure. 2. The following patients (control group) admitted to the internal medicine intensive care unit of Samsung Seoul Hospital 1) Age 18 or older 2) Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- If any of the following criteria applies, participants will not be permitted to participate in this clinical trial.
- Patients 48 hours after oxygen treatment (HFNC, NIV (BIPAP or CPAP), MV)
- Patients transferred from another hospital
- Patients with limitations in treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Mortality
Time frame: From date of admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year
clinical outcomes - Hospital Mortality
3 secondary outcomes
ICU Mortality
Time frame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 6 months
Hospital length of stay
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 1 years
ICU length of stay
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryoung Eun Ko, MD, PhD (+82-2-3410-6399, koryoungeun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: From date of admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.