Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT03461133
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2018-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Early Warning Scoring on Surgical Normal Wards
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-01', 'size': 501633, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-04T09:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3827}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-04', 'studyFirstSubmitDate': '2018-02-25', 'studyFirstSubmitQcDate': '2018-03-04', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In hospital cardiac arrests', 'timeFrame': 'on average 14 days per patient, cumulative over 12 months in each observed cohort', 'description': 'Patient cardiac arrests during stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues', 'Emergencies']}, 'referencesModule': {'references': [{'pmid': '22998715', 'type': 'BACKGROUND', 'citation': 'Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.'}, {'pmid': '26317569', 'type': 'BACKGROUND', 'citation': 'Ludikhuize J, Brunsveld-Reinders AH, Dijkgraaf MG, Smorenburg SM, de Rooij SE, Adams R, de Maaijer PF, Fikkers BG, Tangkau P, de Jonge E; Cost and Outcomes of Medical Emergency Teams Study Group. Outcomes Associated With the Nationwide Introduction of Rapid Response Systems in The Netherlands. Crit Care Med. 2015 Dec;43(12):2544-51. doi: 10.1097/CCM.0000000000001272.'}, {'pmid': '24686020', 'type': 'BACKGROUND', 'citation': 'Muller MP, Richter T, Papkalla N, Poenicke C, Herkner C, Osmers A, Brenner S, Koch T, Schwanebeck U, Heller AR. Effects of a mandatory basic life support training programme on the no-flow fraction during in-hospital cardiac resuscitation: an observational study. Resuscitation. 2014 Jul;85(7):874-8. doi: 10.1016/j.resuscitation.2014.03.046. Epub 2014 Mar 28.'}, {'pmid': '28288655', 'type': 'BACKGROUND', 'citation': 'Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.'}]}, 'descriptionModule': {'briefSummary': 'Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. Upon meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to these patients. The present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.', 'detailedDescription': 'The deployment of an electronic monitoring and notification system is accompanied by data acquisition over 12 months (intervention) using four routine databases: Hospital patient data management, anesthesia database, local data of the German Resuscitation Registry, and measurement logs of the automated patient monitoring and alert system (intervention period only). A preceding time period of 12 months served as control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General surgery, vascular surgery, thoracic surgery,', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to one of the participating wards\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03461133', 'briefTitle': 'Automated Early Warning Scoring on Surgical Normal Wards', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Carl Gustav Carus'}, 'officialTitle': 'Detection of Deteriorating Patients on Peripheral Surgical Wards by an Automated Notification System', 'orgStudyIdInfo': {'id': 'DrePaSiNet'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reference', 'description': 'All patients admitted to the participating surgical wards from 2015-01-01 to 2015-12-31'}, {'label': 'Intervention', 'description': 'All patients admitted to the participating surgical wards from 2016-07-01 to 2017-06-30', 'interventionNames': ['Other: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'OTHER', 'otherNames': ['Automated early warning score and notification system'], 'description': 'The emergency notification system is linked to a paging system to the surgeon in charge and to the Hospital Medical Emergency Team. Depending on individual Multiparameter Early Warning Score communication protocols are activated.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'University Hospital Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Axel R. Heller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Dresden, GERMANY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Carl Gustav Carus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Emergency Services', 'investigatorFullName': 'Axel R. Heller', 'investigatorAffiliation': 'University Hospital Carl Gustav Carus'}}}}