- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04032288
Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
July 23, 2019 updated by: Kuo-Chen Cheng, Chimei Medical Center
The registration system will enroll and follow up ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.
The diagnosis of ARDS must be made by an intensivist or chest physician.
Including characteristics, co-morbidities, clinical features, laboratory data, organs dysfunction, treatments and outcomes of ARDS patients will be recorded.
Study Overview
Status
Completed
Conditions
Detailed Description
Acute respiratory distress syndrome (ARDS) is defined as a syndrome of acute and persistent lung inflammation with increased vascular permeability and characterized by three clinical features: bilateral radiographic infiltrates; a PaO2/FiO2 ratio of 200 mmHg or less, regardless of the level of PEEP and no clinical evidence for an elevated left atrial pressure.
If measured, the pulmonary capillary wedge pressure is 18 mmHg or less.
In 1994, the American-European Consensus Conference on acute respiratory distress syndrome (ARDS) issued the above definitions that have been widely used by clinicians and researchers (1, 2) When patients with acute respiratory distress syndrome (ARDS), an age-adjusted incidence of 64 per 100,000 person-years and a mortality of 41 percent were detected.
Within intensive care units, approximately ten to 15 percent of admitted patients and up to 20 percent of mechanically ventilated patients meet criteria for ARDS (3-6).
The mortality rate varies on the basis of the underlying cause, with most patients dying of multi-organ system failure rather than isolated respiratory insufficiency (5, 7).
Large trials suggest that the overall mortality of ARDS ranges from 26 to 58 percent (8, 9).
The better outcomes always came from tertiary medical centers or big clinical trials, which somewhat might conceal the fact of presence of higher mortality.
The mortality rate in our hospital ever reached or even up to 67.2%(10).
To improve the quality of care in ARDS patients still has a long way to.
We hope to establish a prospective registration system to understand the real status of quality of care first, and then quality improvement interventions will be followed.
Study Type
Observational
Enrollment (Actual)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan, 710
- Department of Intensive Care Medicine; Chi Mei Medical Center
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.
Description
Inclusion Criteria:
- ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.
Exclusion Criteria:
- NA.
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 |
---|---|---|
mortality
Time Frame: 1 year
|
Hospital Mortality Rate
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kuo-Chen Cheng, Chief, Chi Mei Medical 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
October 11, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 11, 2016
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
July 23, 2019
First Posted (Actual)
July 25, 2019
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CMFHR10154(IRB10110-009)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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