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NCT02178982 Clinical Trial

Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— APT  

Official title:
Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02178982
Other study ID # ARDS protocol treatments
Secondary ID
Status Completed
Phase Phase 4
First received June 10, 2014
Last updated June 23, 2015
Start date May 2014
Est. completion date June 2015

Study information
Verified date June 2015
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhongda Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of medical staff who comply the protocol treatment 2 years Yes
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