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Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT01704066

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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The study is composed of 3 phases:

Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as provided by the consensus panel. The possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ARDS.

Phase 2: Training materials adapted according to the recently published Berlin definition of ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all participants.

Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.

Conditions

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Acute Respiratory Distress Syndrome

Keywords

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ARDS Chest radiograph Berlin Definition Inter-observer agreement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Training and education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* intensivists working in the participating ICUs

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Critical Care Medicine, China

OTHER

Sponsor Role lead

Responsible Party

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Bin Du

Professor and Director, Medical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Du, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 28107822 (View on PubMed)

Other Identifiers

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2012BAI11B05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CCCCTG-2012-ARDS-01

Identifier Type: -

Identifier Source: org_study_id