- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02178982
Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome (APT)
June 23, 2015 updated by: Jianfeng Xie, Southeast University, China
The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.
In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients.
There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients.
Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
134
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
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Zhongda hospital
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ARDS patients
Description
Inclusion Criteria:
- aged ≥ 18 years
- admitted to the ICU
- according to the diagnostic criteria of ARDS Berlin definition,admit patients with severe ARDS
Exclusion Criteria:
- age <18 years old
- be expected to die within 24 hours
- end-stage malignancies
- be participating in other studies, which may affect the results of this study
- DNI (do not intubation) and DNR (do not recovery) patients
- family members do not agree to sign an informed consent
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
standard treatments of ARDS
|
|
protocol treatment of ARDS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of medical staff who comply the protocol treatment
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 10, 2014
First Submitted That Met QC Criteria
June 27, 2014
First Posted (Estimate)
July 1, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2015
Last Update Submitted That Met QC Criteria
June 23, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARDS protocol treatments
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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