Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

May 30, 2020 updated by: Jongmin Lee, Seoul St. Mary's Hospital
This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours after intensive care unit (ICU) admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality rate
Time Frame: Through study completion, an average of 1 year
Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF
Through study completion, an average of 1 year
Hospital mortality rate
Time Frame: Through study completion, an average of 1 year
Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Study Director: Jongmin Lee, Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (ACTUAL)

June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU_RES_VIRUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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