Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT01402635
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2011-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can the Point-Of-Care Chemistry Test (POCT) Solve the Emergency Department (ED) Crowding?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003441', 'term': 'Crowding'}], 'ancestors': [{'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-22', 'studyFirstSubmitDate': '2011-01-09', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay', 'timeFrame': 'average 7days from ED visit(up to time of discharge at ED or admission to ward)', 'description': 'Time interval between registration at ED and leaving at ED(discharge, admission, etc.)'}], 'secondaryOutcomes': [{'measure': 'length of stay(subgroup)', 'timeFrame': 'average 7days from ED visit (up to time of discharge at ED or admission to ward)', 'description': 'length of stay analysis for Emergency Severity Index (ESI) 3-4, admission or discharge group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['crowding', 'Point-of-Care Systems', 'emergency medicine'], 'conditions': ['Crowding']}, 'referencesModule': {'references': [{'pmid': '20825817', 'type': 'BACKGROUND', 'citation': 'Lee EJ, Shin SD, Song KJ, Kim SC, Cho JS, Lee SC, Park JO, Cha WC. A point-of-care chemistry test for reduction of turnaround and clinical decision time. Am J Emerg Med. 2011 Jun;29(5):489-95. doi: 10.1016/j.ajem.2009.11.020. Epub 2010 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study that the Point-Of-Care Chemistry Test (POCT) may shorten Emergency Department (ED) length of stay (LOS).', 'detailedDescription': 'ED crowding is one of the most serious problems in ED. POCT has shorter turn-around time compared to centralized laboratory system. If POCT introduce to ED, it may help to shorten LOS of ED patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 15 years\n* clinically required to have chemistry lab tests\n* ESI 2-5\n* written agreement to participate\n\nExclusion Criteria:\n\n* no agreement\n* ESI level 1\n* no chemistry lab'}, 'identificationModule': {'nctId': 'NCT01402635', 'acronym': 'POCTED', 'briefTitle': 'Can the Point-Of-Care Chemistry Test (POCT) Solve the Emergency Department (ED) Crowding?', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Central Laboratory and Point-of-care Chemistry Test for Solving the Emergency Department Crowding', 'orgStudyIdInfo': {'id': 'SNUEMS201101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POCT lab', 'description': 'The patient group whose laboratory test perform by POCT chemistry analyzer.', 'interventionNames': ['Device: point-of-care chemistry test(POCT) (Piccolo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'central laboratory group(CLT)', 'description': 'The patients group whose laboratory test perform by central laboratory.', 'interventionNames': ['Device: point-of-care chemistry test(POCT) (Piccolo)']}], 'interventions': [{'name': 'point-of-care chemistry test(POCT) (Piccolo)', 'type': 'DEVICE', 'otherNames': ['Piccolo® xpress', 'Piccolo® Comprehensive Metabolic Reagent Disc'], 'description': 'comprehensive chemistry POCT including ALB, ALP, ALT, AST, BUN, Ca, Cl-, Cre, Glu, K+, Na+, TBil, TCO2, TP It takes 12minutes to perform analyze.', 'armGroupLabels': ['POCT lab', 'central laboratory group(CLT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang Do Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Sang Do Shin', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}