Acute Respiratory FailureNCT04411368
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure
An observational study of Acute Respiratory Failure and Acute Respiratory Distress Syndrome, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 540 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue. * Definition of acute respiratory failure: Patients who met one of following criteria 1. SaO2 < 90% on room air 2. SaO2 < 92% on > 6L/min of oxygen 3. Respiratory rates > 30/min, or sign of respiratory distress
Who may be able to join
- Male or female aged ≥ 19 years
- Written informed consent by the patient or legally authorized representative
- Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation
Who cannot join
- No informed consent
- A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul, 06591
Jongmin Lee, M.D., 82-10-6300-7128, dibs03@gmail.com
About this study
This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of respiratory viral infections
Rate of respiratory viral infections in patients with acute respiratory failure
Measured: within 24 hours after intensive care unit (ICU) admission
Secondary outcomes (2)
ICU mortality rate
Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF
Measured: Through study completion, an average of 1 year
Hospital mortality rate
Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongmin Lee, Seoul St. Mary's Hospital
- Investigators
- Jongmin Lee, Study director, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411368
- Sponsor's protocol ID
- ICU_RES_VIRUS
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04411368
- Acronym / sponsor ID
- ICU_RES_VIRUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jun 2020 (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.
This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue. * Definition of acute respiratory failure: Patients who met one of following criteria 1. SaO2 < 90% on room air 2. SaO2 < 92% on > 6L/min of oxygen 3. Respiratory rates > 30/min, or sign of respiratory distress
Key inclusion criteria (3 listed)
- Male or female aged ≥ 19 years
- Written informed consent by the patient or legally authorized representative
- Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation
Key exclusion criteria (2 listed)
- No informed consent
- A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability
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
Rate of respiratory viral infections
Time frame: within 24 hours after intensive care unit (ICU) admission
Rate of respiratory viral infections in patients with acute respiratory failure
2 secondary outcomes
ICU mortality rate
Time frame: Through study completion, an average of 1 year
Hospital mortality rate
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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. This study is not recruiting at the moment.
Jongmin Lee study director
Seoul St. Mary's Hospital
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 and Acute Respiratory Distress Syndrome, run by Seoul St. Mary's Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jongmin Lee, Ph.D (+821063007128, dibs03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of respiratory viral infections (time frame: within 24 hours after intensive care unit (ICU) admission). 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 2 Jun 2020.