NCT02178982

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 10, 2014

Last Update Submit

June 23, 2015

Conditions

Keywords

mechanical ventilationARDSVentilator strategyoutcome

Outcome Measures

Primary Outcomes (1)

  • Number of medical staff who comply the protocol treatment

    2 years

Study Arms (2)

standard treatments of ARDS

protocol treatment of ARDS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ARDS patients

You may qualify if:

  • aged ≥ 18 years
  • admitted to the ICU
  • according to the diagnostic criteria of ARDS Berlin definition,admit patients with severe ARDS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongda Hospital

Study Record Dates

First Submitted

June 10, 2014

First Posted

July 1, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations