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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2012-10-06', 'studyFirstSubmitQcDate': '2012-10-10', 'lastUpdatePostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS', 'timeFrame': 'immediately after reading the CXRs'}], 'secondaryOutcomes': [{'measure': 'Impact of the training set on the inter-observer agreement on the interpretation of CXRs', 'timeFrame': 'difference of inter-observer agreement before and after the training course'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ARDS', 'Chest radiograph', 'Berlin Definition', 'Inter-observer agreement'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '28107822', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAs 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.\n\nIn 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.\n\nThe objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.', 'detailedDescription': 'The study is composed of 3 phases:\n\nPhase 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.\n\nPhase 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.\n\nPhase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensivists working in the participating ICUs', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intensivists working in the participating ICUs\n\nExclusion Criteria:\n\n* those who could not participate both questionnaire surveys\n* those who have read the reference with the training set of CXRs before the study\n* those who have already known the objective of the study'}, 'identificationModule': {'nctId': 'NCT01704066', 'briefTitle': 'Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Society of Critical Care Medicine, China'}, 'officialTitle': 'Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition', 'orgStudyIdInfo': {'id': 'CCCCTG-2012-ARDS-01'}, 'secondaryIdInfos': [{'id': '2012BAI11B05', 'type': 'OTHER_GRANT', 'domain': 'National Key Technology R&D Program Project 2012BAI11B05'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Training and education', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Bin Du, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Society of Critical Care Medicine, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Medical ICU', 'investigatorFullName': 'Bin Du', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}