NCT01704066

Brief Summary

The original American-European Consensus Conference (AECC) definition of Acute Respiratory Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR using this definition among intensivists and radiologists. As a result, the newly published Berlin definition of ARDS specified that the CXR criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on CXR. In order to improve inter-observer agreement, the panel have also developed a set of CXRs judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS. The objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

October 6, 2012

Last Update Submit

December 20, 2012

Conditions

Keywords

ARDSChest radiographBerlin DefinitionInter-observer agreement

Outcome Measures

Primary Outcomes (1)

  • inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS

    immediately after reading the CXRs

Secondary Outcomes (1)

  • Impact of the training set on the inter-observer agreement on the interpretation of CXRs

    difference of inter-observer agreement before and after the training course

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensivists working in the participating ICUs

You may qualify if:

  • intensivists working in the participating ICUs

You may not qualify if:

  • those who could not participate both questionnaire surveys
  • those who have read the reference with the training set of CXRs before the study
  • those who have already known the objective of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Peng JM, Qian CY, Yu XY, Zhao MY, Li SS, Ma XC, Kang Y, Zhou FC, He ZY, Qin TH, Yin YJ, Jiang L, Hu ZJ, Sun RH, Lin JD, Li T, Wu DW, An YZ, Ai YH, Zhou LH, Cao XY, Zhang XJ, Sun RQ, Chen EZ, Du B; China Critical Care Clinical Trial Group (CCCCTG). Does training improve diagnostic accuracy and inter-rater agreement in applying the Berlin radiographic definition of acute respiratory distress syndrome? A multicenter prospective study. Crit Care. 2017 Jan 20;21(1):12. doi: 10.1186/s13054-017-1606-4.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Bin Du, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Medical ICU

Study Record Dates

First Submitted

October 6, 2012

First Posted

October 11, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations