Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT03006692
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014474', 'term': 'Unconsciousness'}], 'ancestors': [{'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2016-12-27', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': '220 patients in 1.5 year', 'description': 'Will there be fewer observational diagnosis'}], 'secondaryOutcomes': [{'measure': 'Doctor satisfaction', 'timeFrame': '220 patients in 1.5 year', 'description': 'Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unconscious (Psychology)']}, 'referencesModule': {'references': [{'pmid': '30885262', 'type': 'DERIVED', 'citation': 'Zwisler ST, Zincuk Y, Bering CB, Zincuk A, Nybo M, Mikkelsen S. Diagnostic value of prehospital arterial blood gas measurements - a randomised controlled trial. Scand J Trauma Resusc Emerg Med. 2019 Mar 18;27(1):32. doi: 10.1186/s13049-019-0612-8.'}]}, 'descriptionModule': {'briefSummary': 'In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas testing is present since 2014. This study will determine if a prehospital arterial blood gas helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be determined if the doctors find this device helpful in assessing and treating patients with affected consciousness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '220 patients seen prehospital by the mobile emergency care unit in Odense, Denmark. Patients have to have impaired consciousness (Glasgow Coma Scale \\< 13).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GCS \\< 13\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* detained or imprisoned patient'}, 'identificationModule': {'nctId': 'NCT03006692', 'acronym': 'ABL', 'briefTitle': 'Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients', 'orgStudyIdInfo': {'id': 'ABL Laegebil Odense'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Take arterial blood gas', 'description': 'Patients with impaired consciousness are randomised into having analysed a arterial blood gas.', 'interventionNames': ['Other: With arterial blood gas, parameters not being normal can be corrected']}, {'label': 'Do not take arterial blood gas', 'description': 'Patients with impaired consciousness are randomised into not having analysed a arterial blood gas.'}], 'interventions': [{'name': 'With arterial blood gas, parameters not being normal can be corrected', 'type': 'OTHER', 'description': 'If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g. electrolytes, oxygenation and so forth).', 'armGroupLabels': ['Take arterial blood gas']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-5000', 'city': 'Odense C', 'state': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist, ph.d.', 'investigatorFullName': 'Stine Zwisler', 'investigatorAffiliation': 'Odense University Hospital'}}}}