Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
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.
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.
Study:
NCT01704066
Study Brief:
Protocol Section:
NCT01704066