Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT01704066
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2012-10-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Society of Critical Care Medicine, China
Organization:
Study Overview
Official Title:
Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012BAI11B05 | OTHER_GRANT | National Key Technology R&D Program Project 2012BAI11B05 | View |