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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704066
• Other study ID #: CCCCTG-2012-ARDS-01
• Secondary ID: 2012BAI11B05
• Status: Completed
• Phase: N/A
• First received: October 6, 2012
• Last updated: December 20, 2012
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Society of Critical Care Medicine, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Key Technology R&D Program
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Training and education

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Society of Critical Care Medicine, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS		immediately after reading the CXRs	No
Secondary	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	No